VYSIS ALK BREAK APART FISH PROBE KIT
FDA premarket approval P110012/S006 · decided 2014-07-16
Approval details
- PMA number
- P110012
- Supplement
- S006
- Supplement type
- 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
- 2014-06-16
- Decision date
- 2014-07-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- MODIFY THE VALIDATED TEST METHOD MDP00644 FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.
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