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510(k) K903231

Device
COULOCHEM II
Applicant
ESA, INC.
510(k) number
K903231
Product code
LEQ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-09-27
Date received
1990-07-23
Regulation
862.2260
Classification name
Detectors, Electrochemical, Liquid Chromatography
Medical specialty
Clinical Chemistry
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PRENTISS C HIGGINS
Address
45 Wiggins Ave. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LEQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962574WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)Waters Corporation1996-07-22
K864729NEUROCHEMICAL ANALYZEREsa, Inc.1987-04-13
K801439MODEL 5100 ELECTROCHEMICAL DETECTOREnvironmental Sciences Assoc., Inc.1980-07-21

Legacy Summary#

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FDA Review#

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