The following data is part of a premarket notification filed by Sd Biosensor, Inc. with the FDA for Sd A1ccare System, Sd A1ccare Spoit Type Test Kit, Sd Hba1c Control Set.
| Device ID | K140827 |
| 510k Number | K140827 |
| Device Name: | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SD Biosensor, Inc. C-4th & 5th Floor Digital Empire Building 980-3 Yeongtong-dong, Yeongtong-gu Suwon-si, KR 443-702 |
| Contact | Yeon Park |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | LCP |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2015-09-30 |
| Summary: | summary |