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510(k) K802621

Device
Emit-stm Ethyl Alcohol Assay
Applicant
SYVA CO.
510(k) number
K802621
Product code
DMT
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-10-20
Regulation
862.3040
Classification name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K934273KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)Eastman Kodak Company1994-03-21
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