The following data is part of a premarket notification filed by Andon Medical Co., Ltd. with the FDA for Blood Glucose Monitoring System, Models Ag-6081 And Ag-6951.
| Device ID | K101307 |
| 510k Number | K101307 |
| Device Name: | BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ANDON MEDICAL CO., LTD. 04-23-3 AIRPORT INDUSTRIAL PK Tianjin, CN 300381 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON MEDICAL CO., LTD. 04-23-3 AIRPORT INDUSTRIAL PK Tianjin, CN 300381 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-10 |
| Decision Date | 2011-08-09 |
| Summary: | summary |