PMA P850062S003

Device
ABBOTT ANTI-DELTA (EIA) ASSAY
Applicant
Abbott Laboratories
PMA number
P850062
Supplement
S003
Product code
LQI
Decision date
2002-09-05
Classification
Microbiology
Generic name
HEPATITIS DELTA SEROLOGICAL REAGENTS
Approval order statement
APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.

Current openFDA PMA Record#

Device
ABBOTT ANTI-DELTA (EIA) ASSAY
Applicant
Abbott Laboratories
PMA number
P850062
Supplement
S003
Product code
LQI
Generic name
HEPATITIS DELTA SEROLOGICAL REAGENTS
Decision date
2002-09-05
Decision code
APPR
Date received
2001-10-03
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.