AUTODELFIA HAFP KIT
FDA premarket approval P970037/S005 · decided 2011-04-08
Approval details
- PMA number
- P970037
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Trade name
- AUTODELFIA HAFP KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2011-03-17
- Decision date
- 2011-04-08
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- CHANGE IN A RAW MATERIAL USED IN THE MANUFACTURE OF THE ENHANCEMENT SOLUTION AUXILIARY REAGENT USED WITH THE AUTODELFIA HAFP KIT.
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