PathVysion HER-2 DNA Probe Kit
FDA premarket approval P980024/S022 · decided 2022-03-18
Approval details
- PMA number
- P980024
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PathVysion HER-2 DNA Probe Kit
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2022-02-18
- Decision date
- 2022-03-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Extension of expiration dating of certain assay pretreatment reagent kit components.
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