Cleared Traditional

GERMCO TEST R GLUCOSE TEST KIT

K810567 · Fermco Biochemics, Inc. · Chemistry
Mar 1981
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K810567 is an FDA 510(k) clearance for the GERMCO TEST R GLUCOSE TEST KIT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Fermco Biochemics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981, 10 days after receiving the submission on March 3, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K810567 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1981
Decision Date March 13, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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