REP FLUR CHOLESTEROL-60 KIT— 510(k) K964471

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K964471 for REP FLUR CHOLESTEROL-60 KIT, Substantially Equivalent on 1996-12-23. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Advisory panel: Clinical Chemistry
Date received: 1996-11-07
Decision date: 1996-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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