PATHVYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024 · decided 1998-12-11
Approval details
- PMA number
- P980024
- 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
- 1998-06-16
- Decision date
- 1998-12-11
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Approval for the PathyVysion(TM) HER-2 DNA Probe Kit. The PathyVysion(TM) HER-2 DNA Probe Kit (PathyVysion Kit) is designed to detect amplification ofthe HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded human breast cancer tissue speciments. Results from the PathVysion Kit are intended for use as an adjuncto to existing clinical and pathologic information currently used as prognostic factors in state II, node-positive breast cancer patients. The Pa
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