PMA P980024S021
- Device
- PathVysion HER-2 DNA Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S021
- Product code
- MVD
- Decision date
- 2020-12-11
- Generic name
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- Approval order statement
- use of alternative parts for in-process testing
Current openFDA PMA Record#
- Device
- PathVysion HER-2 DNA Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S021
- Product code
- MVD
- Generic name
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- 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