PATHVYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024/S005 · decided 2011-04-18
Approval details
- PMA number
- P980024
- Supplement
- S005
- Supplement type
- 135 Review Track For 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
- 2011-02-22
- Decision date
- 2011-04-18
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF PROCESS CHANGES TO THE MANUFACTURE OF THE PATHVYSION HER-2 DNA PROBE KIT ASSAY, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, AND RNA REDUCTION STEP, NEW SONICATION EQUIPMENT, AND A NEW AMINATION/LABELING PROCEDURE.
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