Cleared Traditional

ADVIA 1650 CHOLINESTERASE ASSAY

K013750 · Bayer Diagnostics Corp. · Chemistry
Jan 2002
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K013750 is an FDA 510(k) clearance for the ADVIA 1650 CHOLINESTERASE ASSAY, a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 18, 2002, 66 days after receiving the submission on November 13, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number K013750 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2001
Decision Date January 18, 2002
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIH — Colorimetry, Cholinesterase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3240

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