PMA P790032
- Device
- CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
- Applicant
- Incstar Corp.
- PMA number
- P790032
- Supplement
- S003
- Product code
- LOK
- Decision date
- 1993-07-23
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Current openFDA PMA Record#
- Device
- CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
- Applicant
- Incstar Corp.
- PMA number
- P790032
- Supplement
- S003
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 1993-07-23
- Decision code
- APPR
- Date received
- 1991-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier