CPK ISOENZYME CONTROL— 510(k) K770555

Substantially Equivalent

Bio-Reagents & Diagnostics, Inc.

FDA 510(k) clearance K770555 for CPK ISOENZYME CONTROL, Substantially Equivalent on 1977-06-03. Applicant: Bio-Reagents & Diagnostics, Inc..

Clearance details

Applicant: Bio-Reagents & Diagnostics, Inc.
Product code: Code JJT
Advisory panel: Clinical Chemistry
Date received: 1977-03-21
Decision date: 1977-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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