Cleared Traditional

KING DIAGNOSTICS GLUCOSE-O TEST

K811883 · King Diagnostics, Inc. · Chemistry
Jul 1981
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K811883 is an FDA 510(k) clearance for the KING DIAGNOSTICS GLUCOSE-O TEST, a Orthotoluidine, Glucose (Class II — Special Controls, product code CGE), submitted by King Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 23, 1981, 22 days after receiving the submission on July 1, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K811883 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1981
Decision Date July 23, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGE — Orthotoluidine, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345