REP 3 QUTO-FLUR CHOLESTEROL-30— 510(k) K962914

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K962914 for REP 3 QUTO-FLUR CHOLESTEROL-30, Substantially Equivalent on 1997-01-13. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Advisory panel: Clinical Chemistry
Date received: 1996-07-26
Decision date: 1997-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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