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510(k) K954073

Device
STC DIAGNOSTICS LSD MICRO-PLATE EIA
Applicant
SOLARCARE TECHNOLOGIES CORP,INC.
510(k) number
K954073
Product code
DLB  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-29
Date received
1995-08-30
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
R. SAM NIEDBALA
Address
1745 Eaton Ave. Bethlehem PA US 18018 18018

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
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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