INFORM HER-2/NEU
FDA premarket approval P940004/S001 · decided 2000-08-01
Approval details
- PMA number
- P940004
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFORM HER-2/NEU
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2000-07-10
- Decision date
- 2000-08-01
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- RAW MATERIAL SUBSTITUTION OF REPLACING NONIDET P-40, RAW MATERIAL WITH IGEPAL CA-630, AND CHANGES FOR THE USE OF DRY POWDERS OR SOLUTIONS THAT ARE PURCHASED RATHER THAN MANUFACTURED WHILE KEEPING THE FINAL FORMULATION AND SPECIFICATIONS THE SAME.
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510(k) clearances by this applicant
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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 |