Cleared Traditional

SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607

K091846 · Beckman Coulter, Inc. · Chemistry
Oct 2009
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K091846 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 16, 2009, 116 days after receiving the submission on June 22, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K091846 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2009
Decision Date October 16, 2009
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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