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510(k) K924733

Device
ETHYL ALCOHOL CALIBRATORS & CONTROL
Applicant
DIAGNOSTIC REAGENTS, INC.
510(k) number
K924733
Product code
DNN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-09
Date received
1992-09-22
Regulation
862.3200
Classification name
Calibrators, Ethyl Alcohol
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
YUH-GENG TSAY
Address
110 Pioneer Way Mountain View CA US 94041 94041

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DNN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.1999-03-31
K973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.1997-10-01
K882117ETHYL ALCOHOL STANDARDVerichem Laboratories, Inc.1988-08-04
K853532ALCOHOL CALIBRATORSDiagnostic Systems1985-09-16
K810466ETHYL ALCOHOL SERUM CALIBRATORSyva Co.1981-03-06
K802620EMIT-STM ETHYL ALCOHOL URINE CALIBRATORSyva Co.1980-10-31

Legacy Summary#

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FDA Review#

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