CGL
8 FDA 510(k) clearances · Product code
119 daysmedian time to decision
453 days90th percentile
8clearances measured
FDA profile
- Official device name
- Electrode, Ion Based, Enzymatic, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2013: 6 · 2017: 14 · 2018: 11 · 2019: 25 · 2020: 19 · 2021: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| i-STAT Crea cartridge with the i-STAT 1 System (K261039) | Abbott Point of Care, Inc. | 2026-06-26 |
| Nova StatSensor Creatinine Hospital Meter System (K171059) | Nova Biomedical Corporation | 2017-05-26 |
| EPOC CHLORIDE TEST AND EPOC CREATININE TEST (K113726) | Epocal, Inc. | 2012-10-05 |
| NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS (K070068) | Nova Biomedical Corp. | 2007-05-07 |
| ABL8X7 FLEX (K051968) | Radiometer Medical Aps | 2006-10-16 |
| STAT PROFILE M7 ANALYZER (K991727) | Nova Biomedical Corp. | 1999-07-16 |
| I-STAT SYSTEM (K973292) | I-Stat Corp. | 1997-10-20 |
| RENALYZER PRX 90 (K903034) | Swedish Trade Council USA | 1991-03-13 |
Track CGL automatically
Every clearance here is in the API, with alerts when new ones post.