REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM— 510(k) K904035

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K904035 for REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM, Substantially Equivalent on 1990-11-09. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code LBT
Advisory panel: Clinical Chemistry
Date received: 1990-08-31
Decision date: 1990-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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