VYSIS ALK BREAK APART FISH PROBE KIT
FDA premarket approval P110012/S001 · decided 2012-06-07
Approval details
- PMA number
- P110012
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VYSIS ALK BREAK APART FISH PROBE KIT
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2011-12-19
- Decision date
- 2012-06-07
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR THE HUMAN PLACENTAL (HP) DNA COMPONENT FOR THE DEVICE, PER DESIGN VERIFICATION PROTOCOL MD17892.
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