PMA P990026S004
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S004
- Product code
- CGA
- Decision date
- 2001-08-03
- Classification
- Clinical Chemistry
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Approval order statement
- CHANGE IN MANUFACTURING METHODS AND PROCEDURES TO UPGRADE FROM A MANUAL PROCESS AT CYGNUS, INC. TO AN EXPANDED AUTOMATED PROCESS AT CORIUM MANUFACTURING GROUP.
Current openFDA PMA Record#
- Device
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S004
- Product code
- CGA
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Decision date
- 2001-08-03
- Decision code
- OK30
- Date received
- 2001-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN MANUFACTURING METHODS AND PROCEDURES TO UPGRADE FROM A MANUAL PROCESS AT CYGNUS, INC. TO AN EXPANDED AUTOMATED PROCESS AT CORIUM MANUFACTURING GROUP.