PMA P980024S022
- Device
- PathVysion HER-2 DNA Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S022
- Product code
- MVD
- Decision date
- 2022-03-18
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order statement
- Extension of expiration dating of certain assay pretreatment reagent kit components.
Current openFDA PMA Record#
- Device
- PathVysion HER-2 DNA Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S022
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2022-03-18
- Decision code
- OK30
- Date received
- 2022-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extension of expiration dating of certain assay pretreatment reagent kit components.