Product code CGA
- Device name
- Glucose Oxidase, Glucose
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1345
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990026S017 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2003-06-17 |
| P990026S016 | GLUCOWATCH G2 BIOGRAPHER | Animas Corp. | 2002-12-31 |
| P990026S015 | GLUCOWATCH G2 BIOGRAPHER | Animas Corp. | 2002-09-23 |
| P990026S008 | GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-08-26 |
| P990026S014 | GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-08-23 |
| P990026S013 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-07-25 |
| P990026S011 | GLUCOWATCH 2 BIOGRAPHER | Animas Corp. | 2002-03-21 |
| P990026S012 | CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-02-04 |
| P990026S010 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-11-30 |
| P990026S009 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-11-30 |
| P990026S007 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-10-25 |
| P990026S006 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-09-04 |
| P990026S005 | GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-08-28 |
| P990026S004 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-08-03 |
| P990026S002 | GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-05-22 |
| P990026S001 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-05-03 |
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