PMA P970037S009
- Device
- AUTODELFIA HAFP TEST SYSTEM
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S009
- Product code
- LOK
- Decision date
- 2016-08-23
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order 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.
Current openFDA PMA Record#
- Device
- AUTODELFIA HAFP TEST SYSTEM
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S009
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2016-08-23
- Decision code
- OK30
- Date received
- 2016-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.