MYT
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Biosensor, Immunoassay, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| I-STAT CREATINE KINASE MB (CK-MB) (K051433) | I-Stat Corporation | 2005-12-15 |
| BIOCENTREX CARDIAC PANEL (K033155) | Biocentrex | 2004-01-12 |
| QUANTECH CK-MB ASSAY (K984433) | Quantech , Ltd. | 1999-11-01 |
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Every clearance here is in the API, with alerts when new ones post.