PMA P150041S008
- Device
- Vysis CLL FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P150041
- Supplement
- S008
- Product code
- PNK
- Decision date
- 2026-02-18
- Classification
- Pathology
- Generic name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
- Approval order statement
- implementation of a secondary packaging process
Current openFDA PMA Record#
- Device
- Vysis CLL FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P150041
- Supplement
- S008
- Product code
- PNK
- Generic name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
- Decision date
- 2026-02-18
- Decision code
- OK30
- Date received
- 2026-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a secondary packaging process