The following data is part of a premarket notification filed by Sd Biosensor with the FDA for Sd Lipidocare Professional System, Sd Lipidocare Home System, Sd Lipidocare Bt Professional System, Sd Lipidocare Bt Home System.
| Device ID | K160282 |
| 510k Number | K160282 |
| Device Name: | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home 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 443-813 |
| Contact | Sunok Go |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | NBW |
| Subsequent Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2017-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809319396161 | K160282 | 000 |
| 00887473000313 | K160282 | 000 |
| 00887473000283 | K160282 | 000 |
| 00887473000320 | K160282 | 000 |