ADVIA Centaur AFP Readypack Reagents
FDA premarket approval P930036/S015 · decided 2020-08-25
Approval details
- PMA number
- P930036
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA Centaur AFP Readypack Reagents
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2020-07-31
- Decision date
- 2020-08-25
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Procedure for testing raw materials, in-process and final products.
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|---|---|---|
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