Cleared Traditional

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

K984228 · Columbia Bioscience, Inc. · Immunology

Feb 1999

Decision

69d

Days

Class 2

Risk

K984228 is an FDA 510(k) clearance for the IS ANTI-TPO IGG ELISA TEST SYSTEM. This device is classified as a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO).

Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on February 2, 1999, 69 days after receiving the submission on November 25, 1998.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number	K984228 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 1998
Decision Date	February 02, 1999
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF