TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046— 510(k) K900422

Name: FDA 510(k) clearance K900422
Creator: U.S. Food and Drug Administration
Published: 1990-02-27

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K900422 for TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046, Substantially Equivalent on 1990-02-27. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code CZP
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1990-01-30
Decision date: 1990-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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