510(k) K940242

Device: VENTANA CEA PRIMARY ANTIBODY
Applicant: VENTANA MEDICAL SYSTEMS, INC.
510(k) number: K940242
Product code: DFD
Decision: Substantially Equivalent (SESE)
Decision date: 1996-12-23
Date received: 1994-01-19
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: Summary
Third party reviewed: No

Applicant Contact#

Contact: KATHLEEN WINDALL
Address: 3865 N. Business Center Dr. Tucson AZ US 85705 85705

Source Documents#

Other 510(k) Records For Product Code DFD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K924578	PSA ANTIBODY KIT	Ventana Medical Systems, Inc.	1993-02-05
K924629	PAP ANTIBODY KIT	Ventana Medical Systems, Inc.	1993-02-04

Legacy Summary#

summary

FDA Review#

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