PATHWAY ANTI-HER-2/NEU
FDA premarket approval P990081/S007 · decided 2007-12-12
Approval details
- PMA number
- P990081
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Trade name
- PATHWAY ANTI-HER-2/NEU
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2007-11-19
- Decision date
- 2007-12-12
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- CHANGE IN THE RAW MATERIAL USED TO MANUFACTURE CELL LINE MULTIBLOCKS TO ELIMINATE BACKGROUND STAINING OF THE CONTROL SLIDES.
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510(k) clearances by this applicant
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|---|---|---|
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| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| 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 |