PMA P990026S009
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S009
- Product code
- CGA
- Decision date
- 2001-11-30
- Classification
- Clinical Chemistry
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Approval order statement
- APPROVAL FOR THE GLUCOWATCH ANALYZER SOFTWARE PACKAGE AS AN ACCESSORY TO THE GLUCOWATCH BIOGRAPHER.
Current openFDA PMA Record#
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S009
- Product code
- CGA
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Decision date
- 2001-11-30
- Decision code
- APPR
- Date received
- 2001-10-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE GLUCOWATCH ANALYZER SOFTWARE PACKAGE AS AN ACCESSORY TO THE GLUCOWATCH BIOGRAPHER.