510(k) K940243
- Device
- VENTANA EMA PRIMARY ANDIBODY
- Applicant
- VENTANA MEDICAL SYSTEMS, INC.
- 510(k) number
- K940243
- Product code
- DHF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-07
- Date received
- 1994-01-19
- Regulation
- 866.5065
- Classification name
- D/km-1, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- 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#
Legacy Summary#
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FDA Review#
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