CGE · Class II · 21 CFR 862.1345

FDA Product Code CGE: Orthotoluidine, Glucose

Leading manufacturers include Icn Pharmaceuticals, Inc., Harleco and Mallinckrodt Critical Care.

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 Feb 17, 1989
SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
K890335
Alpkem Corp.
Chemistry · 25d
Cleared Jan 22, 1986
GLUCOSE REAGENT SET
K855185
Technostics Intl.
Chemistry · 27d
Cleared Jun 10, 1985
GLUCOSE
K850930
Dilab, Inc.
Chemistry · 95d
Cleared May 01, 1984
DIRECT GLUCOSE REAGENT SET
K841054
Medical Specialties, Inc.
Chemistry · 50d
Cleared Jul 13, 1982
DIRECT GLUCOSE REAGENT SET
K821198
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE-O TEST
K811883
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jan 26, 1981
6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
K810089
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Mar 21, 1979
ORTHO-TOLUIDINE REAGENT SET
K790319
Fisher Scientific Co., LLC
Toxicology · 34d
Cleared Aug 31, 1978
GLUCOLOUR
K781308
Analytical & Research Chemicals, Inc.
Chemistry · 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
Cleared May 03, 1977
GLUCOSE PROCEDURE, TEKPOINT DIRECT
K770455
Icn Pharmaceuticals, Inc.
Chemistry · 56d

About Product Code CGE - Regulatory Context