AUTODELFIA HAFP TEST SYSTEM
FDA premarket approval P970037/S009 · decided 2016-08-23
Approval details
- PMA number
- P970037
- Supplement
- S009
- 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
- 2016-07-27
- Decision date
- 2016-08-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- Modification of two of the incoming quality control test methods performed for the bovine serum albumin (BSA) raw material and Change of the environmental ISO classification.
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