The following data is part of a premarket notification filed by Sd Biosensor with the FDA for Sd Gluconfc Blood Glucose Monitoring System, Sd Gluconfc Multi Blood Glucose Monitoring System.
| Device ID | K151265 |
| 510k Number | K151265 |
| Device Name: | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SD BIOSENSOR C-4TH&5TH, 16, DEOGYEONG-DAERO, 1556BEON-GIL, YEONGTONG-GU Suwon-si, KR 363-951 |
| Contact | Yeon Park |
| Correspondent | Priscilla Chung LK CONSULTING GROUP USA, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2015-11-24 |
| Summary: | summary |