Cleared Traditional

K061382 - ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 (FDA 510(k) Clearance)

K061382 · Beckman Coulter, Inc. · Immunology device

Jul 2006

Decision

49d

Days

Class 2

Risk

K061382 is an FDA 510(k) clearance for the ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on July 6, 2006, 49 days after receiving the submission on May 18, 2006.

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

Submission Details

510(k) Number	K061382 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 18, 2006
Decision Date	July 06, 2006
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF