AUTODELFIA HAFP KIT
FDA premarket approval P970037/S002 · decided 2009-04-08
Approval details
- PMA number
- P970037
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AUTODELFIA HAFP KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2008-09-17
- Decision date
- 2009-04-08
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR A CHANGE IN THE PRODUCTION SITE OR THE TWO ANTIBODIES USED IN THE AUTODELIA HAFP KIT TO WALLAC OY, TURK, FINLAND, AND FOR A CHANGE IN THE ANTIGEN SOURCE IN THE HAFP STANDARDS OF THE AUTODELIA HAFP KIT.
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