QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)— 510(k) K791723

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K791723 for QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN), Substantially Equivalent on 1979-10-01. Applicant: Organon, Inc..

Clearance details

Applicant: Organon, Inc.
Product code: Code JJT
Advisory panel: Clinical Chemistry
Date received: 1979-08-30
Decision date: 1979-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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