PMA P990026S015
- Device
- GLUCOWATCH G2 BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S015
- Product code
- CGA
- Decision date
- 2002-09-23
- Classification
- Clinical Chemistry
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO FULLY AUTOMATE THE AUTOSENSOR ASSEMBLY PROCESS.
Current openFDA PMA Record#
- Device
- GLUCOWATCH G2 BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S015
- Product code
- CGA
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Decision date
- 2002-09-23
- Decision code
- OK30
- Date received
- 2002-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO FULLY AUTOMATE THE AUTOSENSOR ASSEMBLY PROCESS.