Vysis CLL FISH Probe Kit
FDA premarket approval P150041/S003 · decided 2018-07-11
Approval details
- PMA number
- P150041
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vysis CLL FISH Probe Kit
- Generic name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2018-06-15
- Decision date
- 2018-07-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- PNK
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Manufacturing process scale ranges.
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