FDA.reportPublic FDA data

510(k) K920600

Device
DAB DETECTION KIT
Applicant
VENTANA MEDICAL SYSTEMS, INC.
510(k) number
K920600
Product code
DEY  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-11
Date received
1992-02-11
Regulation
866.5550
Classification name
Igm, 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
PHILLIP MILLER
Address
3865 N. Business Center Dr. Tucson AZ US 85705 85705

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DEY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932386VENTANA RED DETECTION KITVentana Medical Systems, Inc.1993-08-09
K920566AEC DETECTION KITVentana Medical Systems, Inc.1992-05-08

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