FDA Product Code
FDA Product Code OAM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1550
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123986 | ACTIM PROM | Alere Scarborough, Inc. | 2014-01-09 | Traditional | PDF ↗ |
| K061886 | ACTIM PROM AND CONTROLS | Medix Biochemica | 2007-01-25 | Traditional | PDF ↗ |
Product code OAM · Class I · Clinical Chemistry. Data: openFDA.