DIH · Class I · 21 CFR 862.3240

FDA Product Code DIH: Colorimetry, Cholinesterase

Leading manufacturers include Sclavo, Inc., Sigma Diagnostics, Inc. and Eastman Kodak Company.

26
Total
26
Cleared
127d
Avg days
1979
Since

FDA 510(k) Cleared Colorimetry, Cholinesterase Devices (Product Code DIH)

26 devices
1–24 of 26
Cleared Feb 07, 2011
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373
Beckman Coulter, Inc.
Toxicology · 82d
Cleared Jul 03, 2006
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093
Roche Diagnostics Corp.
Toxicology · 75d
Cleared Feb 21, 2003
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045
Olympus America, Inc.
Chemistry · 46d
Cleared Jun 26, 2000
ADVIA IMS
K001344
Bayer Corp.
Chemistry · 60d
Cleared Feb 05, 1996
IL TEST CHOLINESTERASE
K943367
Instrumentation Laboratory CO
Chemistry · 572d
Cleared Jan 24, 1996
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
K955498
Diagnostic Chemicals , Ltd.
Toxicology · 54d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (CHE)
K913198
Eastman Kodak Company
Chemistry · 39d
Cleared Jul 01, 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217
Eastman Kodak Company
Chemistry · 42d
Cleared Mar 28, 1989
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272
Sigma Chemical Co.
Chemistry · 96d
Cleared Jan 27, 1989
ATYPICAL CHOLINESTERASE
K873496
Sclavo, Inc.
Chemistry · 528d
Cleared Jan 27, 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049
Sclavo, Inc.
Chemistry · 387d
Cleared Jan 27, 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199
Sclavo, Inc.
Chemistry · 380d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
K883890
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Sep 17, 1986
CHOLINESTERASE (BTC) REAGENT
K863203
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Sep 16, 1986
CHOLINESTERASE (PTC) REAGENT
K863202
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Sep 11, 1986
CHOLINESTERASE
K863111
J. D. Assoc.
Toxicology · 29d
Cleared Jun 27, 1986
RAICHEM CHOLINESTERASE REAGENT
K862168
Reagents Applications, Inc.
Toxicology · 18d
Cleared Oct 17, 1979
CHOLINESTERASE REAGENT
K791725
Gilford Diagnostics
Toxicology · 47d

About Product Code DIH - Regulatory Context