ANTI-TG IGG ELISA TEST SYSTEM— 510(k) K983553

Name: FDA 510(k) clearance K983553
Creator: U.S. Food and Drug Administration
Published: 1998-12-07

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K983553 for ANTI-TG IGG ELISA TEST SYSTEM, Substantially Equivalent on 1998-12-07. Applicant: Columbia Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1998-10-09
Decision date: 1998-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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