Cleared Special

K031269 - ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (FDA 510(k) Clearance)

K031269 · Beckman Coulter, Inc. · Immunology device

May 2003

Decision

11d

Days

Class 2

Risk

K031269 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS. This device is classified as a System, Test, Thyroglobulin (Class II - Special Controls, product code MSW).

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 2, 2003, 11 days after receiving the submission on April 21, 2003.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K031269 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 21, 2003
Decision Date	May 02, 2003
Days to Decision	11 days
Submission Type	Special
Review Panel	Immunology (IM)
Summary	Summary PDF