Product code MYT— Clinical Chemistry
BIOCENTREX CARDIAC PANEL
- Classification name
- Biosensor, Immunoassay, Cpk Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code MYT
FDA has cleared devices under product code MYT between 1999 and 2005, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2004
- 1999
Top applicants under product code MYT
Recent clearances under product code MYT
Data sourced from openFDA. This site is unofficial and independent of the FDA.