ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
FDA premarket approval P930036 · decided 1995-09-29
Approval details
- PMA number
- P930036
- Trade name
- ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 1993-10-18
- Decision date
- 1995-09-29
- Days to decision
- 711 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE CIBA CORNING ACS AFP IMMUNOASSAY
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