Cleared Traditional

ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS

K080481 · Beckman Coulter, Inc. · Chemistry
Feb 2009
Decision
364d
Days
Class 2
Risk

About This 510(k) Submission

K080481 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on February 20, 2009, 364 days after receiving the submission on February 22, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K080481 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2008
Decision Date February 20, 2009
Days to Decision 364 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DDR — Myoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5680

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