MYT — Biosensor, Immunoassay, Cpk Or Isoenzymes Class II
FDA Device Classification
Classification Details
- Product Code
- MYT
- Device Class
- Class II
- Regulation Number
- 862.1215
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K051433 | i-stat corporation | I-STAT CREATINE KINASE MB (CK-MB) | December 15, 2005 |
| K033155 | biocentrex | BIOCENTREX CARDIAC PANEL | January 12, 2004 |
| K984433 | quantech | QUANTECH CK-MB ASSAY | November 1, 1999 |