PATH VYSION HER-2 DNA PROBE KIT ASSAY
FDA premarket approval P980024/S007 · decided 2012-12-20
Approval details
- PMA number
- P980024
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2012-06-14
- Decision date
- 2012-12-20
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR THE MANUFACTURING CHANGE TO COMPONENTS OF THE PROBECHEK HER-2/NEU CUTOFF CONTROL SLIDES USED IN THE PATHVYSION HER-2 DNA PROBE KIT. THE CHANGE INCLUDED CREATION OF A NEW MASTER CELL BANK AND A NEW WORKING CELL BANK FROM SEED STOCK OF HS578T CELLS, USED IN THE MANUFACTURE OF THE PROBECHEK HER-2/NEU CUTOFFCONTROL SLIDES.
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