PMA P990026S005
- Device
- GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S005
- Product code
- CGA
- Decision date
- 2001-08-28
- Classification
- Clinical Chemistry
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER.
Current openFDA PMA Record#
- Device
- GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S005
- Product code
- CGA
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Decision date
- 2001-08-28
- Decision code
- APPR
- Date received
- 2001-08-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER.