Panels › Clinical Chemistry › Product code CGL · Class 2
Electrode, Ion Based, Enzymatic, Creatinine
Regulation 862.1225
1510(k)s in 12 months (8 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in CGL
| Company | 510(k)s | Recalls |
|---|---|---|
| Nova Biomedical Corp. | 3 | 4 |
| Radiometer America Inc | 0 | 3 |
| Abbott Point of Care, Inc. | 1 | 1 |
| Epocal, Inc. | 1 | 0 |
| I-Stat Corp. | 1 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Radiometer Medical Aps | 1 | 0 |
| Swedish Trade Council USA | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2026 | K261039 | i-STAT Crea cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CGL |
| May 26, 2017 | K171059 | Nova StatSensor Creatinine Hospital Meter System Nova Biomedical Corporation | CGL |
| Oct 5, 2012 | K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST Epocal, Inc., CA | CGL |
| May 7, 2007 | K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS Nova Biomedical Corp. | CGL |
| Oct 16, 2006 | K051968 | ABL8X7 FLEX Radiometer Medical Aps, DK | CGL |
| Jul 16, 1999 | K991727 | STAT PROFILE M7 ANALYZER Nova Biomedical Corp. | CGL |
| Oct 20, 1997 | K973292 | I-STAT SYSTEM I-Stat Corp. | CGL |
| Mar 13, 1991 | K903034 | RENALYZER PRX 90 Swedish Trade Council USA | CGL |
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