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510(k) K843872

Device
Ethanol Controls Low & High E5133/e5258
Applicant
SIGMA CHEMICAL CO.
510(k) number
K843872
Product code
DKC
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-31
Date received
1984-10-02
Regulation
862.3280
Classification name
Alcohol Control Materials
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEO BRESSLER
Address
P.O. Box 14508 St. Louis MO US 63178 63178

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
K833514TOXI CHEM SERUM ALCOHOL CONTROLFisher Diagnostics1983-12-08
K810465EMIT-ST ETHYL ALCOHOL SERUM CONTROLSSyva Co.1981-03-06
K802618EMIT-STM ETHYL ALCOHOL URINE CONTROLSSyva Co.1980-10-31