CPK ISOENZYME REAGENT— 510(k) K781124

Name: FDA 510(k) clearance K781124
Creator: U.S. Food and Drug Administration
Published: 1978-08-10

Substantially Equivalent

Electrophoresis Corp. of America

FDA 510(k) clearance K781124 for CPK ISOENZYME REAGENT, Substantially Equivalent on 1978-08-10. Applicant: Electrophoresis Corp. of America. Device class: 2.

Clearance details

Applicant: Electrophoresis Corp. of America
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1978-07-03
Decision date: 1978-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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