REP CHOLESTEROL PROFILE KIT— 510(k) K992971

Name: FDA 510(k) clearance K992971
Creator: U.S. Food and Drug Administration
Published: 1999-10-18

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K992971 for REP CHOLESTEROL PROFILE KIT, Substantially Equivalent on 1999-10-18. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1999-09-03
Decision date: 1999-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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