REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL— 510(k) K980650

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K980650 for REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL, Substantially Equivalent on 1998-05-01. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Advisory panel: Clinical Chemistry
Date received: 1998-02-19
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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