PMA P970037S001
- Device
- AUTODELFIA HAFP TEST KIT
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S001
- Product code
- LOK
- Decision date
- 2002-11-27
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE PATIENT AND PHYSICIAN BROCHURES AND 3 VERSIONS OF THE PACKAGE INSERT FOR THE LABORATORY.
Current openFDA PMA Record#
- Device
- AUTODELFIA HAFP TEST KIT
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S001
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2002-11-27
- Decision code
- APPR
- Date received
- 2002-10-18
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE PATIENT AND PHYSICIAN BROCHURES AND 3 VERSIONS OF THE PACKAGE INSERT FOR THE LABORATORY.