Cleared Traditional

APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201

K080123 · Wako Chemicals USA, Inc. · Chemistry
Jul 2008
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K080123 is an FDA 510(k) clearance for the APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on July 17, 2008, 182 days after receiving the submission on January 17, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K080123 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2008
Decision Date July 17, 2008
Days to Decision 182 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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