The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Ge Blood Glucose Monitoring System 180, Ge Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System Gm280, Rightest Blood Glucose Monitoring System Gm280b,.
| Device ID | K170143 |
| 510k Number | K170143 |
| Device Name: | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist. Taichung, TW 40242 |
| Contact | Kay Wu |
| Correspondent | Feng-yu Lee Dynamic Biotech Inc. Dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20883489002420 | K170143 | 000 |
| 00883489002396 | K170143 | 000 |
| 20883489002383 | K170143 | 000 |