VYSIS PATH VYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024/S002 · decided 2006-05-10
Approval details
- PMA number
- P980024
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- VYSIS PATH VYSION HER-2 DNA PROBE KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2005-06-20
- Decision date
- 2006-05-10
- Days to decision
- 324 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT DES PLAINES, DES PLAINES, ILLINOIS.
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