Cleared Special

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

K031269 · Beckman Coulter, Inc. · Immunology
May 2003
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K031269 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS, 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 review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K031269 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MSW — System, Test, Thyroglobulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010