Cleared Traditional

ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495

K080634 · Beckman Coulter, Inc. · Immunology
Aug 2008
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K080634 is an FDA 510(k) clearance for the ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on August 11, 2008, 158 days after receiving the submission on March 6, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K080634 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2008
Decision Date August 11, 2008
Days to Decision 158 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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