PATHVYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024/S009 · decided 2012-12-26
Approval details
- PMA number
- P980024
- Supplement
- S009
- 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
- 2012-11-15
- Decision date
- 2012-12-26
- Days to decision
- 41 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
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