The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Ag-605 Blood Glucose Monitoring System.
| Device ID | K073030 |
| 510k Number | K073030 |
| Device Name: | AG-605 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ANDON HEALTH CO.,LTD YA AN RD NANKAI DISTRICT Tiajin, CN 300190 |
| Contact | Ms. Mona |
| Correspondent | Ms. Mona ANDON HEALTH CO.,LTD YA AN RD NANKAI DISTRICT Tiajin, CN 300190 |
| 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 | 2007-10-26 |
| Decision Date | 2008-07-21 |
| Summary: | summary |