The following data is part of a premarket notification filed by Sd Biosensor, Inc. with the FDA for Sd Gluconavii Mentor Nfc Multi Blood Glucose Monitoring System, And Sd Gluconavii Mentor Nfc Blood Glucose Monitoring System.
| Device ID | K132929 |
| 510k Number | K132929 |
| Device Name: | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SD BIOSENSOR, INC. 27001 LA PAZ RD, SUITE 266B Mission Viejo, CA 92691 |
| Contact | Feng-yu Lee |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-17 |
| Decision Date | 2015-08-05 |
| Summary: | summary |