FDA.reportPublic FDA data

510(k) K812986

Device
AGGLUTEX AMPHETAMINE TEST KIT
Applicant
HOFFMANN-LA ROCHE, INC.
510(k) number
K812986
Product code
DJP  
Decision
Substantially Equivalent (SESE)
Decision date
1982-01-22
Date received
1981-10-26
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K854009ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SPRoche Diagnostic Systems, Inc.1985-10-15
K830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEHoffmann-La Roche, Inc.1983-03-24
K823212ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINEHoffmann-La Roche, Inc.1982-11-29

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases