FDA Product Code
FDA Product Code KHG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7500
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221508 | AnemoCheck Home | Sanguina, Inc. | 2023-09-29 | Traditional | PDF ↗ |
| K163215 | AnemoCheck | Sanguina, LLC | 2017-09-13 | Traditional | PDF ↗ |
| K042379 | ANEMIAPRO SELF-SCREENER | Biosafe Laboratories, Inc. | 2004-12-15 | Traditional | PDF ↗ |
| K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 | Gds Technology | 2002-02-11 | Special | PDF ↗ |
| K001462 | CARESIDE HEMOGLOBIN | Careside, Inc. | 2000-08-21 | Traditional | PDF ↗ |
| K994073 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | 2000-01-14 | Traditional | PDF ↗ |
| K973649 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | 1998-08-31 | Traditional | PDF ↗ |
| K953221 | ABBOTT VISION HEMOGLOBIN (MODIFICATION) | Abbott Laboratories | 1995-09-29 | Traditional | PDF ↗ |
| K934064 | REFLOTRON HEMOGLOBIN TEST TABS | Boehringer Mannheim Corp. | 1993-12-06 | Traditional | PDF ↗ |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Biotrack, Inc. | 1989-10-10 | Traditional | PDF ↗ |
| K885227 | CLINISTAT HEMOGLOBIN REAGENT TEST | Heraeus Kulzer, Inc. | 1989-02-24 | Traditional | PDF ↗ |
| K880038 | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 | Sigma Diagnostics, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K872653 | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 | Em Diagnostic Systems, Inc. | 1987-07-23 | Traditional | PDF ↗ |
| K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | Trace Scientific , Ltd. | 1987-03-16 | Traditional | PDF ↗ |
| K863104 | TOTAL HEMOGLOBIN | J. D. Assoc. | 1986-09-04 | Traditional | PDF ↗ |
| K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | U. S. Diagnostics, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K862202 | VISION(TM) HEMOGLOBIN | Abbott Laboratories | 1986-08-18 | Traditional | PDF ↗ |
| K854687 | ERMA HB-METER MODEL 303N | Future Impex Corp. | 1986-06-04 | Traditional | PDF ↗ |
| K860475 | HEMOGLOBIN REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-03 | Traditional | PDF ↗ |
| K854139 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB | Eastman Kodak Company | 1985-11-05 | Traditional | PDF ↗ |
| K851467 | HEMOGLOBIN ANALYZER | Awareness Technology, Inc. | 1985-07-16 | Traditional | PDF ↗ |
| K851432 | HEMOGLOBIN | Pointe Scientific, Inc., | 1985-07-12 | Traditional | PDF ↗ |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | Worthington Diagnostic Systems | 1983-09-26 | Traditional | PDF ↗ |
| K831813 | CO-OXIMETER CONTROL | United Diagnostics, Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K830180 | REFEREE BRAND CO-OXIMETER REAGENTS | Analytical Products, Inc. | 1983-04-08 | Traditional | PDF ↗ |
| K830590 | CORNING 2500 CO-OXIMETER | Corning Medical & Scientific | 1983-04-05 | Traditional | PDF ↗ |
| K823060 | HEMOGLOBIN REAGENT | Biorent Diagnostic, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K822045 | SERALYZER HEMOGLOBIN TEST MODULE | Miles Laboratories, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K822044 | SERALYZER HEMOGLOBIN REAGENT STRIPS | Miles Laboratories, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K821658 | HEMOGLOBIN REAGENT | Anco Medical Reagents & Assoc. | 1982-06-25 | Traditional | PDF ↗ |
| K820596 | CYANMETHEMOGLOBIN TEST | Boehringer Mannheim Corp. | 1982-03-26 | Traditional | PDF ↗ |
| K803248 | AMES SERA-PAK HEMOGLOBIN REAGENT | Miles Laboratories, Inc. | 1981-01-26 | Traditional | PDF ↗ |
| K802268 | CRC(CYANMETHEMOGLOBIN REAGENT CONCENT | R&D Systems, Inc. | 1980-12-31 | Traditional | PDF ↗ |
| K802568 | HEMOGLOBIN CONTROL | Marilyn L. Amick | 1980-11-12 | Traditional | PDF ↗ |
| K802569 | ABNORMAL HEMOGLOBIN CONTROL | Marilyn L. Amick | 1980-11-12 | Traditional | PDF ↗ |
| K801268 | HEMOGLOBIN CONTROL LEVELS | Bioscientific | 1980-07-14 | Traditional | PDF ↗ |
| K800059 | COMPUR M-1000 MINI-PHOTOMETER | Miles Laboratories, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K792503 | SANDARE CYANMETHEMOGLOBIN REAGENT | Sandare Chemical Co., Inc. | 1979-12-31 | Traditional | PDF ↗ |
| K760208 | OXIMETER, CO-, IL MODEL 282 | Instrumentation Laboratory CO | 1976-07-26 | Traditional | PDF ↗ |
Product code KHG · Class II · Hematology. Data: openFDA.