VYSIS ALK BREAK APART FISH PROBE KIT
FDA premarket approval P110012/S005 · decided 2013-11-27
Approval details
- PMA number
- P110012
- Supplement
- S005
- 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
- 2013-11-05
- Decision date
- 2013-11-27
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- CHANGING THE CONFIGURATION OF THEIR CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE,AND LABEL INSPECTION SYSTEM FOR THE FOLLOWING FISH ASSAYS: VYSIS ALK BREAK APART FISH PROBE KIT, UROVYSION BLADDER CANCER KIT, AND PATHVYSION HER-2DNA PROBE KIT.
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