ClearanceBrief
Panels › Clinical Chemistry › Product code CGE · Class 2

Orthotoluidine, Glucose

Regulation 862.1345

0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in CGE

Decided510(k)Device and applicantCode
Feb 17, 1989K890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
Alpkem Corp.
CGE
Jan 22, 1986K855185GLUCOSE REAGENT SET
Technostics Intl.
CGE
Jun 10, 1985K850930GLUCOSE
Dilab, Inc.
CGE
May 1, 1984K841054DIRECT GLUCOSE REAGENT SET
Medical Specialties, Inc.
CGE
Jul 13, 1982K821198DIRECT GLUCOSE REAGENT SET
Omega Medical Electronics
CGE
Jul 23, 1981K811883KING DIAGNOSTICS GLUCOSE-O TEST
King Diagnostics, Inc.
CGE
Jan 26, 1981K8100896% ORTHO LOLIUDINE REAGENT IN GLACID ACI
Anco Medical Reagents & Assoc.
CGE
Mar 21, 1979K790319ORTHO-TOLUIDINE REAGENT SET
Fisher Scientific Co., LLC
CGE
Aug 31, 1978K781308GLUCOLOUR
Analytical & Research Chemicals, Inc.
CGE
Aug 3, 1977K771314GLUCOSE REAGENT (O-TOLUIDINE)
Mallinckrodt Critical Care
CGE
Jul 21, 1977K771091UNIPAK GLUCOSE
Harleco
CGE
May 3, 1977K770455GLUCOSE PROCEDURE, TEKPOINT DIRECT
Icn Pharmaceuticals, Inc.
CGE

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