PATH VYSION HER-2 DNA PROBE KIT ASSAY
FDA premarket approval P980024/S008 · decided 2012-07-17
Approval details
- PMA number
- P980024
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PATH VYSION HER-2 DNA PROBE KIT ASSAY
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2012-06-21
- Decision date
- 2012-07-17
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR CHANGES TO PATHVYSION LABELING IN ORDER TO PROVIDE CUSTOMERS WITH CONSISTENT, CURRENT, AND CLEAR INFORMATION.
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