FDA Registration
Active
🇺🇸 United States
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Reg #: 2245578
·
FEI: 2245578
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ABBOTT POINT OF CARE INC.
- Registration Number
- 2245578
- FEI Number
- 2245578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 400 College Road East
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210958
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Ph Rate Measurement, Carbon-Dioxide | JFL | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2021-08-25 |
Proprietary Names
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Establishment Types
Complaint File Establishment per 21 CFR 820.198