VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES
FDA premarket approval P110012/S003 · decided 2013-04-17
Approval details
- PMA number
- P110012
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2013-03-20
- Decision date
- 2013-04-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- THREE MANUFACTURING CHANGES, INCLUDING THE ADDITION OF A WORKING CELL BANK, IMPLEMENTATION OF A PRE-FERMENTATION OPTICAL DENSITY READING, AND MODIFICATION TO PROPAGATING THE CELL LINE USED TO MAKE NEGATIVE CONTROL SLIDES.
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