The following data is part of a premarket notification filed by Microtech Medical, Inc. with the FDA for Gochek Blood Glucose Monitoring System, Gochek Connect Blood Glucose Monitoring System.
| Device ID | K193340 |
| 510k Number | K193340 |
| Device Name: | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | MicroTech Medical, Inc. 3350 Scott Blvd, Bldg.64 Santa Clara, CA 95045 |
| Contact | Dore Mark |
| Correspondent | Mingzi Hussey Zi-Medical, Inc 253 Summer St Somerville, MA 02143 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06958590303046 | K193340 | 000 |
| 06958590302520 | K193340 | 000 |