REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222— 510(k) K940679

Name: FDA 510(k) clearance K940679
Creator: U.S. Food and Drug Administration
Published: 1994-09-09

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K940679 for REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222, Substantially Equivalent on 1994-09-09. 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: 1994-02-09
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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