I-STAT CREATINE KINASE MB (CK-MB)— 510(k) K051433
Substantially EquivalentI-Stat Corporation
FDA 510(k) clearance K051433 for I-STAT CREATINE KINASE MB (CK-MB), Substantially Equivalent on 2005-12-15. Applicant: I-Stat Corporation.
Clearance details
- Applicant
- I-Stat Corporation
- Product code
- Code MYT
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Windsor, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.