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510(k) K963002

Device
ACTIVE ANDROSTENEDIONE EIA
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
510(k) number
K963002
Product code
CIZ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-08-16
Date received
1996-08-02
Regulation
862.1075
Classification name
Radioimmunoassay, Androstenedione
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN WILLIS
Address
445 Medical Center Blvd. Webster TX US 77598 77598

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CIZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954755COAT-A-COUNT DIRECT ANDROSTENEDIONEDiagnostic Products Corp.1995-11-29
K934751ACTIVE ANDROSTANEDIOL GLUCURONIDEDiagnostic Systems Laboratories, Inc.1994-01-10
K860559ANDROSTENEDIONE 125I KIT BY RIAImmuchem Corp.1986-03-14
K854673DSL ANDROSTENEDIONE RIA (DSL # 4200)Diagnostic Systems Laboratories, Inc.1986-01-22
K854650DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)Diagnostic Systems Laboratories, Inc.1985-12-13
K844398COAT-A-COUNT ANDROSTENEDIONE RIA KITDiagnostic Products Corp.1984-12-10
K842960ANDROSTENEDIONE BY RIARadioassay Systems Laboratories, Inc.1984-09-27
K832452ANDROSTENEDIONE TEST SET 125IWien Laboratories, Inc.1983-09-12
K801729ANDROSTENEDIONE RADIOIMMUNOASSAY KITDiagnostics Biochem Canada, Inc.1980-10-31

Legacy Summary#

summary

FDA Review#

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