PMA P990026S010
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S010
- Product code
- CGA
- Decision date
- 2001-11-30
- Classification
- Clinical Chemistry
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Approval order statement
- APPROVAL FOR EXTENDED SHELF LIFE OF THE QC TEST SOLUTION FROM 6 MONTHS TO 24 MONTHS.
Current openFDA PMA Record#
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S010
- Product code
- CGA
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Decision date
- 2001-11-30
- Decision code
- APPR
- Date received
- 2001-11-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EXTENDED SHELF LIFE OF THE QC TEST SOLUTION FROM 6 MONTHS TO 24 MONTHS.