The following data is part of a premarket notification filed by Sinocare Meditech, Inc. with the FDA for Gold Aq Blood Glucose Monitoring System.
| Device ID | K170264 |
| 510k Number | K170264 |
| Device Name: | Gold AQ Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Sinocare Meditech, Inc. No. 265 Guyuan Road, Hi-tech Zone Changsha, CN 410205 |
| Contact | Qian Zhou |
| Correspondent | Jacqueline Davis Trividia Health, Inc. 2400 NW 55th Ct. Ft. Lauderdale, FL 33309 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-10-05 |