FDA Product Code
FDA Product Code CGL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1225
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2026-06-26 | Traditional | PDF ↗ |
| K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017-05-26 | Special | PDF ↗ |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | Epocal, Inc. | 2012-10-05 | Traditional | PDF ↗ |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | Nova Biomedical Corp. | 2007-05-07 | Traditional | PDF ↗ |
| K051968 | ABL8X7 FLEX | Radiometer Medical Aps | 2006-10-16 | Traditional | PDF ↗ |
| K991727 | STAT PROFILE M7 ANALYZER | Nova Biomedical Corp. | 1999-07-16 | Traditional | PDF ↗ |
| K973292 | I-STAT SYSTEM | I-Stat Corp. | 1997-10-20 | Traditional | PDF ↗ |
| K903034 | RENALYZER PRX 90 | Swedish Trade Council USA | 1991-03-13 | Traditional | PDF ↗ |
Product code CGL · Class II · Clinical Chemistry. Data: openFDA.