PATHVYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024/S010 · decided 2013-02-10
Approval details
- PMA number
- P980024
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PATHVYSION HER-2 DNA PROBE KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2013-01-16
- Decision date
- 2013-02-10
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR HUMAN PLACENTAL (HP) DNA WHICH IS A COMPONENT OF THE PATHVYSION HER-2 DNA PROBE KIT AND THE UROVYSION BLADDER CANCER KIT.
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