Cleared Traditional

K810089 - 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
(FDA 510(k) Clearance)

K810089 · Anco Medical Reagents & Assoc. · Chemistry

Jan 1981

Decision

13d

Days

Class 2

Risk

K810089 is an FDA 510(k) clearance for the 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI, a Orthotoluidine, Glucose (Class II — Special Controls, product code CGE), submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1981, 13 days after receiving the submission on January 13, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K810089 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1981
Decision Date	January 26, 1981
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—