AutoDELFIA hAFP Test Kit
FDA premarket approval P970037/S011 · decided 2018-09-06
Approval details
- PMA number
- P970037
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AutoDELFIA hAFP Test Kit
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2018-08-09
- Decision date
- 2018-09-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- Update of the plate washer manifold, a component of the AutoDELFIA instrument.
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