CK-MB(IMMUNOLOGICAL)— 510(k) K802521

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K802521 for CK-MB(IMMUNOLOGICAL), Substantially Equivalent on 1980-11-12. Applicant: Biodynamics Corp.. Device class: 2.

Clearance details

Applicant: Biodynamics Corp.
Product code: Code JHS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1980-10-15
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.