CGE · Class II · 21 CFR 862.1345

FDA Product Code CGE: Orthotoluidine, Glucose

Leading manufacturers include Harleco, Mallinckrodt Critical Care and Fisher Scientific Co., LLC.

12
Total
12
Cleared
40d
Avg days
1977
Since

FDA 510(k) Cleared Orthotoluidine, Glucose Devices (Product Code CGE)

12 devices
1–12 of 12
Cleared May 01, 1984
DIRECT GLUCOSE REAGENT SET
K841054
Medical Specialties, Inc.
Chemistry · 50d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE-O TEST
K811883
King Diagnostics, Inc.
Chemistry · 22d
Cleared Mar 21, 1979
ORTHO-TOLUIDINE REAGENT SET
K790319
Fisher Scientific Co., LLC
Toxicology · 34d
Cleared Aug 03, 1977
GLUCOSE REAGENT (O-TOLUIDINE)
K771314
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Jul 21, 1977
UNIPAK GLUCOSE
K771091
Harleco
Chemistry · 35d

About Product Code CGE - Regulatory Context