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510(k) K854009

Device
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K854009
Product code
DJP  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-15
Date received
1985-09-30
Regulation
862.3100
Classification name
Radioimmunoassay, Amphetamine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KAFADER II
Address
11 Franklin Ave. Belleville NJ US 07109 07109

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DJP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960526PRIMIDONE EIA TESTDiagnostic Reagents, Inc.1996-03-18
K913866URINE AMPHETAMINE DIRECT RIA KIT (I-125)Immunalysis Corporation1991-09-25
K912755ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINERoche Diagnostic Systems, Inc.1991-08-26
K882228REVISED DOUBLE ANTIBODY AMPHETAMINEDiagnostic Products Corp.1988-08-08
K881817ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINESRoche Diagnostic Systems, Inc.1988-07-29
K830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEHoffmann-La Roche, Inc.1983-03-24
K823212ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINEHoffmann-La Roche, Inc.1982-11-29
K812986AGGLUTEX AMPHETAMINE TEST KITHoffmann-La Roche, Inc.1982-01-22

Legacy Summary#

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FDA Review#

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