Cleared Traditional

K893205 - FIRST CHOICE (TM)
(FDA 510(k) Clearance)

K893205 · Polymer Technology Corp. · Chemistry

Oct 1989

Decision

163d

Days

Class 2

Risk

K893205 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 October 6, 1989, 163 days after receiving the submission on April 26, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K893205 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 1989
Decision Date	October 06, 1989
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—