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510(k) K924578

Device
PSA ANTIBODY KIT
Applicant
VENTANA MEDICAL SYSTEMS, INC.
510(k) number
K924578
Product code
DFD  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-05
Date received
1992-09-10
Regulation
866.5550
Classification name
Kappa, Peroxidase, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN A TLLSON
Address
3865 N. Business Center Dr. Tucson AZ US 85705 85705

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940242VENTANA CEA PRIMARY ANTIBODYVentana Medical Systems, Inc.1996-12-23
K924629PAP ANTIBODY KITVentana Medical Systems, Inc.1993-02-04

Legacy Summary#

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FDA Review#

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