i-STAT Crea cartridge with the i-STAT 1 System
FDA 510(k) clearance K261039 · decided 2026-06-26
Clearance details
- K-number
- K261039
- Device name
- i-STAT Crea cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-30
- Decision date
- 2026-06-26
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- CGL
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.