Cleared Traditional

K822118 - FERMCOTEST CREATININE TEST REAGENT
(FDA 510(k) Clearance)

K822118 · Fermco Biochemics, Inc. · Chemistry

Sep 1982

Decision

73d

Days

Class 2

Risk

K822118 is an FDA 510(k) clearance for the FERMCOTEST CREATININE TEST REAGENT. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX).

Submitted by Fermco Biochemics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982, 73 days after receiving the submission on July 19, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K822118 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 1982
Decision Date	September 30, 1982
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—