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510(k) K936253

Device
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
Applicant
LIGHT DIAGNOSTICS
510(k) number
K936253
Product code
GNM  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-08
Date received
1993-12-30
Regulation
866.3145
Classification name
Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD P TRIGLIA
Address
28835 Single Oak Dr. Temecula CA US 92590 92590

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GNM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K936073ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUSChemicon Intl., Inc.1995-09-08
K936089COXSACKIE A24 VIRUS MONOCLONAL ANTIBODYChemicon Intl., Inc.1995-09-08
K936145COXSACKIEVIRUS B1 MONOCLONAL ANTIBODYChemicon Intl., Inc.1995-09-08
K936251COXSACKIEVIRUS B3 MONOCLONAL ANTIBODYLight Diagnostics1995-09-08
K936252COXSACKIEVIRUS B@ MONOCLONAL ANTIBODYLight Diagnostics1995-09-08
K936254COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODYLight Diagnostics1995-09-08
K940471COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIESChemicon Intl., Inc.1995-09-08
K940472COXSACKIEVIRUS B5 MONOCLONAL ANTIBODYChemicon Intl., Inc.1995-09-08

Legacy Summary#

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FDA Review#

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