PATHVYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024/S004 · decided 2011-01-10
Approval details
- PMA number
- P980024
- Supplement
- S004
- 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
- 2010-12-22
- Decision date
- 2011-01-10
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION TO INCREASE THE BATCH RANGE UP TO 2000 ML.
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