AutoDELFIA hAFP Test System
FDA premarket approval P970037/S012 · decided 2021-08-11
Approval details
- PMA number
- P970037
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AutoDELFIA hAFP Test System
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2021-07-15
- Decision date
- 2021-08-11
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- Adding the WAVE25 system and the Cogent M1 TFF system to the in vitro manufacturing of antibodies.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.