Cleared Traditional

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

K011963 · Bayer Corp. · Chemistry
Nov 2001
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K011963 is an FDA 510(k) clearance for the ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 20, 2001, 151 days after receiving the submission on June 22, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K011963 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2001
Decision Date November 20, 2001
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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