Cleared Traditional

K821198 - DIRECT GLUCOSE REAGENT SET
(FDA 510(k) Clearance)

K821198 · Omega Medical Electronics · Chemistry

Jul 1982

Decision

77d

Days

Class 2

Risk

K821198 is an FDA 510(k) clearance for the DIRECT GLUCOSE REAGENT SET. This device is classified as a Orthotoluidine, Glucose (Class II — Special Controls, product code CGE).

Submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982, 77 days after receiving the submission on April 27, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K821198 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 27, 1982
Decision Date	July 13, 1982
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—