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510(k) K802618

Device
EMIT-STM ETHYL ALCOHOL URINE CONTROLS
Applicant
SYVA CO.
510(k) number
K802618
Product code
DKC  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-10-20
Regulation
862.3280
Classification name
Alcohol Control Materials
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
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 DKC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031392MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROLMedical Analysis Systems, Inc.2003-07-01
K935819QUALITY CONTROL MATERIAL (ASSAYED)Columbia Diagnostics, Inc.1994-03-22
K933425AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812Sigma Diagnostics, Inc.1993-11-16
K934467BECKMAN CX AMMONIA/ALCOHOL CONTROLBeckman-Diagnostic Systems Group1993-10-27
K932067ETHANOL CONTROLS, URINE, LEVELS 1,II, AND IIISigma Diagnostics, Inc.1993-06-16
K912827SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3Cala Diagnostics1991-08-12
K912826WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2Cala Diagnostics1991-07-26
K843872ETHANOL CONTROLS LOW & HIGH E5133/E5258Sigma Chemical Co.1984-10-31
K833514TOXI CHEM SERUM ALCOHOL CONTROLFisher Diagnostics1983-12-08
K810465EMIT-ST ETHYL ALCOHOL SERUM CONTROLSSyva Co.1981-03-06

Legacy Summary#

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FDA Review#

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