Cleared Traditional

FIRST CHOICE(TM), MODIFICATION

K911792 · Polymer Technology Corp. · Chemistry
May 1991
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K911792 is an FDA 510(k) clearance for the FIRST CHOICE(TM), MODIFICATION, 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 May 15, 1991, 23 days after receiving the submission on April 22, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K911792 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1991
Decision Date May 15, 1991
Days to Decision 23 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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