CARDIO REP RECOMBINANT CK ABNORMAL CONTROL— 510(k) K932442

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K932442 for CARDIO REP RECOMBINANT CK ABNORMAL CONTROL, Substantially Equivalent on 1993-10-28. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJT
Advisory panel: Clinical Chemistry
Date received: 1993-05-20
Decision date: 1993-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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