510(k) K261039
- Device
- i-STAT Crea cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc.
- 510(k) number
- K261039
- Product code
- CGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-26
- Date received
- 2026-03-30
- Regulation
- 862.1225
- Classification name
- Electrode, Ion Based, Enzymatic, Creatinine
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Brian Ma
- Address
- 400 College Rd. E. Princeton NJ US 08540 08540
FDA Registration Numbers#
- 3011979858
- 3012817228
- 3013513377
- 3005643513
- 3007490412
- 3006198300
- 3002807968
- 3004959793
- 1219029
- 2245578
- 3023162659
- 3004193489
Source Documents#
Other 510(k) Records For Product Code CGL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017-05-26 |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | Epocal, Inc. | 2012-10-05 |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | Nova Biomedical Corp. | 2007-05-07 |
| K051968 | ABL8X7 FLEX | Radiometer Medical Aps | 2006-10-16 |
| K991727 | STAT PROFILE M7 ANALYZER | Nova Biomedical Corp. | 1999-07-16 |
| K973292 | I-STAT SYSTEM | I-Stat Corp. | 1997-10-20 |
| K903034 | RENALYZER PRX 90 | Swedish Trade Council USA | 1991-03-13 |