Cleared Traditional

FIRST CHOICE(TM)

K912732 · Polymer Technology Corp. · Chemistry
Sep 1991
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K912732 is an FDA 510(k) clearance for the FIRST CHOICE(TM), a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Polymer Technology Corp. (Issaquah, US). The FDA issued a Cleared decision on September 10, 1991, 82 days after receiving the submission on June 20, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K912732 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1991
Decision Date September 10, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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