TITAN GEL REP CPK/LDH ISOENZYME CONTROL— 510(k) K874141

Name: FDA 510(k) clearance K874141
Creator: U.S. Food and Drug Administration
Published: 1987-11-04

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K874141 for TITAN GEL REP CPK/LDH ISOENZYME CONTROL, Substantially Equivalent on 1987-11-04. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJT
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1987-10-13
Decision date: 1987-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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