INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
FDA premarket approval P100027/S004 · decided 2012-11-21
Approval details
- PMA number
- P100027
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2012-09-26
- Decision date
- 2012-11-21
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE CHANGE OF THE TWO LITER (2L) BOTTLES FOR EACH OF THE AQUEOUS-BASED REAGENTS FROM FLUORINATED TO NON-FLUORINATED BOTTLES.
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