AUTODELFIA HAFP TEST KIT
FDA premarket approval P970037 · decided 1998-03-31
Approval details
- PMA number
- P970037
- Trade name
- AUTODELFIA HAFP TEST KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 1997-08-26
- Decision date
- 1998-03-31
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- The device is intended for the quantitative determination of human alpha-fetoprotein (AFP) in maternal serum and amniotic fluid obtained between the 15th and 21st weeks of gestation. The assay is to be peformed on the 1235 AutoDELFIA(TM) automatic immunoassay system, and is intended for use only in conjunction with other diagnostic tools such as ultrasound and amniography as an aid in the detection of Open Neural Tube Defects (ONTDs).
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