Cleared Traditional

AMRESCO PRODUCT NUMBER 7426

K891923 · American Research Products Co. · Chemistry
Jun 1989
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K891923 is an FDA 510(k) clearance for the AMRESCO PRODUCT NUMBER 7426, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on June 20, 1989, 85 days after receiving the submission on March 27, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K891923 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1989
Decision Date June 20, 1989
Days to Decision 85 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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