PMA P990026S007
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S007
- Product code
- CGA
- Decision date
- 2001-10-25
- Classification
- Clinical Chemistry
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Approval order statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT CYGNUS, INC., REDWOOD, CALIFORNIA.
Current openFDA PMA Record#
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S007
- Product code
- CGA
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Decision date
- 2001-10-25
- Decision code
- APPR
- Date received
- 2001-08-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT CYGNUS, INC., REDWOOD, CALIFORNIA.