The following data is part of a premarket notification filed by Yd Diagnostics Corporation with the FDA for Uriscan 10acr Urine Strips On The Uriscan Optima Urine Analyzer.
| Device ID | K182038 |
| 510k Number | K182038 |
| Device Name: | URiSCAN 10ACR Urine Strips On The URiSCAN Optima Urine Analyzer |
| Classification | Enzymatic Method, Creatinine |
| Applicant | YD Diagnostics Corporation 76, Seori-ro, Idong-myeon, Cheoin-gu Yongin-si, KR 17127 |
| Contact | Hyuckjoo Lee |
| Correspondent | Erika B. Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | JFY |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-30 |
| Decision Date | 2018-12-10 |