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510(k) K934273

Device
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
Applicant
EASTMAN KODAK COMPANY
510(k) number
K934273
Product code
DMT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-21
Date received
1993-08-31
Regulation
862.3040
Classification name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
YVONNE E MIDDLEFELL
Address
100 Indigo Creek Dr. Rochester NY US 14652 14652

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DMT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000410SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORSBeckman Coulter, Inc.2000-04-10
K971506SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATORBeckman Instruments, Inc.1997-06-03
K923783ETHYL ALCOHOL ASSAYDiagnostic Reagents, Inc.1993-01-21
K864894EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93Em Diagnostic Systems, Inc.1987-01-09
K843378ETHYL ALCOHOL ASSAY KITDiagnostic Chemicals, Ltd. (Usa)1984-09-14
K810467EMIT-ST SERUM ETHYL ALCOHOL ASSAYSyva Co.1981-03-06
K802621EMIT-STM ETHYL ALCOHOL ASSAYSyva Co.1980-10-31

Legacy Summary#

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FDA Review#

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