PMA P150041S001
- Device
- Vysis CLL Fish Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P150041
- Supplement
- S001
- Product code
- PNK
- Decision date
- 2017-12-06
- Classification
- Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)
- Generic name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
- Approval order statement
- Vendors relocation of a manufacturing site for production of reagents contained in kit components.
Current openFDA PMA Record#
- Device
- Vysis CLL Fish Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P150041
- Supplement
- S001
- Product code
- PNK
- Generic name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
- Decision date
- 2017-12-06
- Decision code
- OK30
- Date received
- 2017-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Vendors relocation of a manufacturing site for production of reagents contained in kit components.