GMP CIQ ELISA TEST KIT— 510(k) K833275

Name: FDA 510(k) clearance K833275
Creator: U.S. Food and Drug Administration
Published: 1984-06-22

Substantially Equivalent

Gamma Medical Products, Inc.

FDA 510(k) clearance K833275 for GMP CIQ ELISA TEST KIT, Substantially Equivalent on 1984-06-22. Applicant: Gamma Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Medical Products, Inc.
Product code: Code DAK
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1983-09-21
Decision date: 1984-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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