IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP
FDA premarket approval P010007/S010 · decided 2018-12-27
Approval details
- PMA number
- P010007
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2018-09-28
- Decision date
- 2018-12-27
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for labeling changes describing the impact of endogenous biotin.
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