Cleared Traditional

COULTER GLUCOSE REAGENT

K897160 · Coulter Electronics, Inc. · Chemistry
Mar 1990
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K897160 is an FDA 510(k) clearance for the COULTER GLUCOSE REAGENT, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 9, 1990, 71 days after receiving the submission on December 28, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K897160 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1989
Decision Date March 09, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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