510(k) DEN170030
- Device
- VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems
- 510(k) number
- DEN170030
- Product code
- PZJ
- Decision
- Unknown (DENG)
- Decision date
- 2017-10-27
- Date received
- 2017-05-30
- Regulation
- 864.1866
- Classification name
- Lynch Syndrome Test System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Carol "Penny" Houston
- Address
- 1910 E. Innovation Park Dr. Tucson AZ US 85755 85755
FDA Registration Numbers#
- 2134567
- 2028492
- 3009972873
- 3004859032
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PZJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260776 | VENTANA MMR IHC Panel | Roche Tissue Diagnostics, Inc. | 2026-10-23 |
| K211181 | Idylla MSI Test | Biocartis NV | 2023-02-27 |
| K213348 | BOND MMR Antibody Panel | Leica Biosystems Newcastle, Ltd. | 2023-02-21 |
| K200129 | OncoMate MSI Dx Analysis System | Promega Corporation | 2021-07-26 |