The following data is part of a premarket notification filed by Dfi Co., Ltd. with the FDA for Cybow Reader, Models 300 & 720.
| Device ID | K102188 |
| 510k Number | K102188 |
| Device Name: | CYBOW READER, MODELS 300 & 720 |
| Classification | Automated Urinalysis System |
| Applicant | DFI CO., LTD. #821 SAMIL PLAZA, 837-26 YEUKSAM-DONG Gangnam-gu, Seoul, KR 135-937 |
| Contact | Yang Ho-dong |
| Correspondent | Yang Ho-dong DFI CO., LTD. #821 SAMIL PLAZA, 837-26 YEUKSAM-DONG Gangnam-gu, Seoul, KR 135-937 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-03 |
| Decision Date | 2011-08-09 |
| Summary: | summary |