GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL— 510(k) K851202

Name: FDA 510(k) clearance K851202
Creator: U.S. Food and Drug Administration
Published: 1985-04-29

Substantially Equivalent

Gilford

FDA 510(k) clearance K851202 for GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL, Substantially Equivalent on 1985-04-29. Applicant: Gilford. Device class: 2.

Clearance details

Applicant: Gilford
Product code: Code DAK
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1985-03-26
Decision date: 1985-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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