The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Ag-607 Blood Glucose Monitoring System And Ag-607 Multi Blood Glucose Monitoring System.
| Device ID | K153561 |
| 510k Number | K153561 |
| Device Name: | AG-607 Blood Glucose Monitoring System And AG-607 Multi Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ANDON HEALTH CO., LTD No. 3 JinPing Street,Ya' An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON HEALTH CO., LTD No. 3 JinPing Street,Ya' An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859811007414 | K153561 | 000 |
| 00859811007261 | K153561 | 000 |
| 00850028714614 | K153561 | 000 |
| 00810084930618 | K153561 | 000 |
| 00810084930625 | K153561 | 000 |
| 00850026094299 | K153561 | 000 |