PMA P790032S001

Device
GAMMA DAB (125I) AFP RIA KIT
Applicant
Incstar Corp.
PMA number
P790032
Supplement
S001
Product code
LOK
Decision date
1986-08-22
Generic name
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Current openFDA PMA Record#

Device
GAMMA DAB (125I) AFP RIA KIT
Applicant
Incstar Corp.
PMA number
P790032
Supplement
S001
Product code
LOK
Generic name
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date
1986-08-22
Decision code
APPR
Date received
1986-06-10
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename