IMMULITE/IMMULITE 2000 AFP
FDA premarket approval P010007/S005 · decided 2011-04-26
Approval details
- PMA number
- P010007
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMULITE/IMMULITE 2000 AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2011-02-18
- Decision date
- 2011-04-26
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL IMMULITE 2000 XPI ANALYZER, AS A FAMILY MEMBER OF THE CURRENTLY CLEARED IMMULITE 2000 ANALYZER.
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