PATHFAST CK-MB-II, PATHFAST MYO-II— 510(k) K081360
Substantially EquivalentMitsubishi Kagaku Iatron
FDA 510(k) clearance K081360 for PATHFAST CK-MB-II, PATHFAST MYO-II, Substantially Equivalent on 2009-08-17. Applicant: Mitsubishi Kagaku Iatron.
Clearance details
- Applicant
- Mitsubishi Kagaku Iatron
- Product code
- Code JHX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.