ADVIA CENTAUR AFP ASSAY
FDA premarket approval P930036/S005 · decided 2012-10-15
Approval details
- PMA number
- P930036
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR AFP ASSAY
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2012-03-26
- Decision date
- 2012-10-15
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
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