FDA Product Code
FDA Product Code NJV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K053196 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) | Inverness Medical Innovations, Inc. | 2005-12-16 | Special | PDF ↗ |
| K023824 | ALBUMIN COBALT BINDING TEST (ACB TEST) | Ischemia Technologies, Inc. | 2003-02-14 | Traditional | PDF ↗ |
Product code NJV · Class II · Clinical Chemistry. Data: openFDA.