PATHWAY ANTI-C-KIT PRIMARY ANTIBODY
FDA premarket approval P020055/S001 · decided 2007-05-16
Approval details
- PMA number
- P020055
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PATHWAY ANTI-C-KIT PRIMARY ANTIBODY
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2007-04-16
- Decision date
- 2007-05-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NKF
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- CHANGE OF SYSTEM OPERATING SOFTWARE FROM DOS TO WINDOWS FOR THE DROP VOLUME TESTER COMPUTER WORKSTATION HARDWARE.
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|---|---|---|
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| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465) | Ventana Medical Systems, Inc. | 2014-03-20 |