Cleared Traditional

FIRST CHOICE

K912580 · Polymer Technology Corp. · Chemistry
Mar 1992
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K912580 is an FDA 510(k) clearance for the FIRST CHOICE, 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 March 4, 1992, 266 days after receiving the submission on June 12, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K912580 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1991
Decision Date March 04, 1992
Days to Decision 266 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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