FDA.reportPublic FDA data

510(k) K860525

Device
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K860525
Product code
DLB  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-11
Date received
1986-02-11
Regulation
862.3580
Classification name
Radioimmunoassay, Lsd (125-i)
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KAFADER II
Address
Div. Of Hoffmann-La Roche, Inc Nutley NJ US 07110 07110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DLB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961436ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)Roche Diagnostic Systems, Inc.1996-06-21
K955448EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLSBehring Diagnostics, Inc.1996-02-23
K955814CEDIA DAU LSD ASSAYMicrogenics Corp.1996-02-09
K954073STC DIAGNOSTICS LSD MICRO-PLATE EIASolarcare Technologies Corp,Inc.1995-11-29
K891167COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KITDiagnostic Products Corp.1989-05-03
K874270REVISED LABELING FOR LSD TEST KITRoche Diagnostic Systems, Inc.1987-11-13

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