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510(k) K961436

Device
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K961436
Product code
DLB  
Decision
Substantially Equivalent (SESE)
Decision date
1996-06-21
Date received
1996-04-15
Regulation
862.3580
Classification name
Radioimmunoassay, Lsd (125-i)
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARIA FEIJOO
Address
Branchburg Township 1080 U.S. Hwy. 202 Somerville NJ US 08876 08876

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
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
K860525ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARDRoche Diagnostic Systems, Inc.1986-04-11

Legacy Summary#

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FDA Review#

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