REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)— 510(k) K901143

Name: FDA 510(k) clearance K901143
Creator: U.S. Food and Drug Administration
Published: 1990-05-23

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K901143 for REP HEMOGLOBIN IEF KITS (CAT. NO. 3250), Substantially Equivalent on 1990-05-23. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code JBD
Device class: Class 2
Regulation: 21 CFR 864.7440
Advisory panel: Hematology
Date received: 1990-03-12
Decision date: 1990-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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