PMA P840070S001

Device
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
Applicant
Organon Teknika Corp.
PMA number
P840070
Supplement
S001
Product code
LOM
Decision date
1990-03-21
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Current openFDA PMA Record#

Device
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
Applicant
Organon Teknika Corp.
PMA number
P840070
Supplement
S001
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
1990-03-21
Decision code
APPR
Date received
1989-08-25
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier