FDA Product Code
FDA Product Code MYT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) | I-Stat Corporation | 2005-12-15 | Traditional | PDF ↗ |
| K033155 | BIOCENTREX CARDIAC PANEL | Biocentrex | 2004-01-12 | Traditional | PDF ↗ |
| K984433 | QUANTECH CK-MB ASSAY | Quantech , Ltd. | 1999-11-01 | Traditional | PDF ↗ |
Product code MYT · Class II · Clinical Chemistry. Data: openFDA.