Atlas FDA

DIH

26 FDA 510(k) clearances · Product code

72 daysmedian time to decision
387 days90th percentile
26clearances measured

FDA profile

Official device name
Colorimetry, Cholinesterase
Device class
Class I (low risk)
Regulation
21 CFR 862.3240
Medical specialty
Clinical Toxicology
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (K103373)Beckman Coulter, Inc.2011-02-07
CHOLINESTERASE GEN.2 TEST SYSTEM (K061093)Roche Diagnostics Corp.2006-07-03
SENTINEL CHOLINESTERASE LIQUID (K051444)Sentinel Ch. Srl2005-06-20
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (K030045)Olympus America, Inc.2003-02-21
WIENER LAB COLINESTERASA AA (K023992)Wiener Laboratories Saic2003-02-12
ADVIA 1650 CHOLINESTERASE ASSAY (K013750)Bayer Diagnostics Corp.2002-01-18
CARESIDE CHOLINESTERASE (K002792)Careside, Inc.2000-11-08
ADVIA IMS (K001344)Bayer Corp.2000-06-26
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (K961656)Eqm Research, Inc.1996-11-26
IL TEST CHOLINESTERASE (K943367)Instrumentation Laboratory CO1996-02-05
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (K955498)Diagnostic Chemicals , Ltd.1996-01-24
IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (K914171)Tech Intl. Co.1991-12-18
KODAK EKTACHEM DT SLIDES (CHE) (K913198)Eastman Kodak Company1991-08-26
CHOLINESTERASE TEST KIT (K912148)Crestat Diagnostics, Inc.1991-08-12
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K912217)Eastman Kodak Company1991-07-01
BECKMAN CHOLINESTERASE REAGENT KIT (K893583)Beckman1989-08-15
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE (K885272)Sigma Chemical Co.1989-03-28
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (K880199)Sclavo, Inc.1989-01-27
ATYPICAL CHOLINESTERASE (K873496)Sclavo, Inc.1989-01-27
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE (K880049)Sclavo, Inc.1989-01-27
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD (K883890)E.I. Dupont DE Nemours & Co., Inc.1988-11-29
CHOLINESTERASE (BTC) REAGENT (K863203)Sigma Diagnostics, Inc.1986-09-17
CHOLINESTERASE (PTC) REAGENT (K863202)Sigma Diagnostics, Inc.1986-09-16
CHOLINESTERASE (K863111)J. D. Assoc.1986-09-11
RAICHEM CHOLINESTERASE REAGENT (K862168)Reagents Applications, Inc.1986-06-27
CHOLINESTERASE REAGENT (K791725)Gilford Diagnostics1979-10-17

Track DIH automatically

Every clearance here is in the API, with alerts when new ones post.