PMA P990026S016

Device
GLUCOWATCH G2 BIOGRAPHER
Applicant
Animas Corp.
PMA number
P990026
Supplement
S016
Product code
CGA
Decision date
2002-12-31
Classification
Clinical Chemistry
Generic name
GLUCOSE OXIDASE, GLUCOSE
Approval order statement
CHANGE IN THE PCBA WASH PROCESS IN THE PCBA ASSEMBLY SEQUENCE TO INCREASE THE EFFICIENCY OF THE PROCESS AND TO REDUCE COST.

Current openFDA PMA Record#

Device
GLUCOWATCH G2 BIOGRAPHER
Applicant
Animas Corp.
PMA number
P990026
Supplement
S016
Product code
CGA
Generic name
GLUCOSE OXIDASE, GLUCOSE
Decision date
2002-12-31
Decision code
OK30
Date received
2002-12-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE PCBA WASH PROCESS IN THE PCBA ASSEMBLY SEQUENCE TO INCREASE THE EFFICIENCY OF THE PROCESS AND TO REDUCE COST.