CREATINE KINASE MB ISOENZYME IMMUNO UV— 510(k) K810861

Name: FDA 510(k) clearance K810861
Creator: U.S. Food and Drug Administration
Published: 1981-04-14

Substantially Equivalent

The Dow Chemical Co.

FDA 510(k) clearance K810861 for CREATINE KINASE MB ISOENZYME IMMUNO UV, Substantially Equivalent on 1981-04-14. Applicant: The Dow Chemical Co.. Device class: 2.

Clearance details

Applicant: The Dow Chemical Co.
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1981-03-31
Decision date: 1981-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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