AUTODELFIA HAFP TEST KIT
FDA premarket approval P970037/S001 · decided 2002-11-27
Approval details
- PMA number
- P970037
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Trade name
- AUTODELFIA HAFP TEST KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2002-10-18
- Decision date
- 2002-11-27
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR LABELING CHANGES TO THE PATIENT AND PHYSICIAN BROCHURES AND 3 VERSIONS OF THE PACKAGE INSERT FOR THE LABORATORY.
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