IS ANTI-TPO IGG ELISA TEST SYSTEM— 510(k) K984228

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K984228 for IS ANTI-TPO IGG ELISA TEST SYSTEM, Substantially Equivalent on 1999-02-02. Applicant: Columbia Bioscience, Inc..

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code JZO
Advisory panel: Immunology
Date received: 1998-11-25
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.