PMA P150041S006
- Device
- Vysis CLL FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P150041
- Supplement
- S006
- Product code
- PNK
- Decision date
- 2020-12-11
- Generic name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
- Approval order statement
- Use of alternative parts for in-process testing.
Current openFDA PMA Record#
- Device
- Vysis CLL FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P150041
- Supplement
- S006
- Product code
- PNK
- Generic name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
- Decision date
- 2020-12-11
- Decision code
- OK30
- Date received
- 2020-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of alternative parts for in-process testing.