Cleared Traditional

DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR

K053090 · Beckman Coulter, Inc. · Chemistry
Dec 2005
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K053090 is an FDA 510(k) clearance for the DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR, a Enzymatic Method, Bilirubin (Class II — Special Controls, product code JFM), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 16, 2005, 44 days after receiving the submission on November 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K053090 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2005
Decision Date December 16, 2005
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFM — Enzymatic Method, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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