REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187— 510(k) K894366

Name: FDA 510(k) clearance K894366
Creator: U.S. Food and Drug Administration
Published: 1989-08-31

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K894366 for REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187, Substantially Equivalent on 1989-08-31. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code LBT
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1989-07-14
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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