REP CHOLESTEROL PROFILE KIT— 510(k) K992971

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K992971 for REP CHOLESTEROL PROFILE KIT, Substantially Equivalent on 1999-10-18. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Advisory panel: Clinical Chemistry
Date received: 1999-09-03
Decision date: 1999-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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