FDA Product Code
FDA Product Code JMG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5340
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K234052 | Access Ferritin | Beckman Coulter, Inc. | 2024-03-20 | Traditional | PDF ↗ |
| K052082 | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | Beckman Coulter, Inc. | 2005-08-19 | Special | PDF ↗ |
| K964282 | TINA-QUANT FERRITIN ASSAY | Boehringer Mannheim Corp. | 1997-07-30 | Traditional | PDF ↗ |
| K971833 | ELECSYS FERRITIN | Boehringer Mannheim Corp. | 1997-06-02 | Traditional | PDF ↗ |
| K963498 | FERR FLEX REAGENT CARTRIDGE | Dade Chemistry Systems, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | Schiapparelli Biosystems, Inc. | 1995-05-16 | Traditional | PDF ↗ |
| K926221 | ACCESS FERRITIN ASSAY | Bio-Rad Laboratories, Inc. | 1993-01-13 | Traditional | PDF ↗ |
| K925848 | IMMULITE FERRITIN | Diagnostic Products Corp. | 1993-01-13 | Traditional | PDF ↗ |
| K920829 | COBAS CORE FERRITIN EIA | Roche Diagnostic Systems, Inc. | 1992-06-19 | Traditional | PDF ↗ |
| K920318 | CEDIA FERRITIN ASSAY | Microgenics Corp. | 1992-06-04 | Traditional | PDF ↗ |
| K902997 | MILENIA (TM) FERRITIN | Diagnostic Products Corp. | 1990-08-02 | Traditional | PDF ↗ |
| K890697 | RIA-GNOST FERRITIN | Cambridge Medical Technology | 1989-03-16 | Traditional | PDF ↗ |
| K881138 | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | Baxter Healthcare Corp | 1988-04-21 | Traditional | PDF ↗ |
| K873730 | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K872955 | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | 1987-08-21 | Traditional | PDF ↗ |
| K840460 | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | Corning Medical & Scientific | 1984-03-30 | Traditional | PDF ↗ |
| K810799 | QUANTIMUNE FERRITIN IRMA | Bio-Rad | 1981-04-03 | Traditional | PDF ↗ |
| K792588 | TERRITIN RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-01-11 | Traditional | PDF ↗ |
| K791096 | RADIOIMMUNOASSAY TEST SYSTEM | Corning Medical & Scientific | 1979-08-03 | Traditional | PDF ↗ |
| K782157 | IRMA TEST, NORDICLAB FERRITIN | Nordiclab Intl. | 1979-01-17 | Traditional | PDF ↗ |
| K781888 | ASSAY SYSTEM, FERRITIN I KIT | New England Nuclear | 1979-01-10 | Traditional | PDF ↗ |
| K781946 | RIA KIT, FERRITIN SOLID PHASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-01-10 | Traditional | PDF ↗ |
| K781844 | FERRITIN KIT | Ria Products, Inc. | 1979-01-10 | Traditional | PDF ↗ |
| K781527 | RIA SYSTEM FOR HUMAN FE-RITIN | Calbiochem-Behring Corp. | 1978-10-03 | Traditional | PDF ↗ |
Product code JMG · Class II · Immunology. Data: openFDA.