The following data is part of a premarket notification filed by Dfi Co., Ltd. with the FDA for Dus 2gp Reagent Strips, Dus 5 Reagent Strips, Dus 10 Reagent Strips.
| Device ID | K181024 |
| 510k Number | K181024 |
| Device Name: | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | DFI Co., Ltd. 388-25, Gomo-ro, Jillye-myeon, Gimhae-si Gyeongsangnam-do, KR 621-881 |
| Contact | Bella Cho |
| Correspondent | Ho Dong Yang Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul, KR 06523 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-18 |
| Decision Date | 2018-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806141302209 | K181024 | 000 |