The following data is part of a premarket notification filed by Alliance International Co., Ltd. with the FDA for Ds-a Blood Glucose Monitoring System.
| Device ID | K082965 |
| 510k Number | K082965 |
| Device Name: | DS-A BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ALLIANCE INTERNATIONAL CO., LTD. NO.58, FU-CHIUN ST. Hsin Chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen ALLIANCE INTERNATIONAL CO., LTD. NO.58, FU-CHIUN ST. Hsin Chu City, TW 30067 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-03 |
| Decision Date | 2009-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812277030044 | K082965 | 000 |
| 00812277030020 | K082965 | 000 |
| 00816703021927 | K082965 | 000 |
| 00816703021910 | K082965 | 000 |
| 00816703021231 | K082965 | 000 |