PMA P980024S019
- Device
- PathVysion HER-2 DNA Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S019
- Product code
- MVD
- Decision date
- 2018-08-29
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order statement
- QC/manufacturing equipment changes and DNA Ladder changes.
Current openFDA PMA Record#
- Device
- PathVysion HER-2 DNA Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S019
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2018-08-29
- Decision code
- OK30
- Date received
- 2018-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- QC/manufacturing equipment changes and DNA Ladder changes.