AUOTDELFIA HAFP KIT
FDA premarket approval P970037/S007 · decided 2012-04-27
Approval details
- PMA number
- P970037
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AUOTDELFIA HAFP KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2011-09-23
- Decision date
- 2012-04-27
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR A CHANGE OF THE DISPENSING LINE USED IN THE MANUFACTURING OF THE CALIBRATORS FOR THE AUTODELFIA AND DELFIA XPRESS HAFP KITS AND THE BUFFER SOLUTION FOR THE DELFIA XPRESS HAFP KIT.
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