Cleared Traditional

K841054 - DIRECT GLUCOSE REAGENT SET
(FDA 510(k) Clearance)

K841054 · Medical Specialties, Inc. · Chemistry

May 1984

Decision

50d

Days

Class 2

Risk

K841054 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 Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984, 50 days after receiving the submission on March 12, 1984.

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

Submission Details

510(k) Number	K841054 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 12, 1984
Decision Date	May 01, 1984
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—