FDA Product Code
FDA Product Code OYG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1117
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111452 | PRESAGE ST2 ASSAY | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011-12-09 | Traditional | PDF ↗ |
Product code OYG · Class II · Clinical Chemistry. Data: openFDA.