The following data is part of a premarket notification filed by Dirui Industrial Co., Ltd. with the FDA for Uristik H Series Reagent Strips For Urinalysis.
| Device ID | K040703 |
| 510k Number | K040703 |
| Device Name: | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | DIRUI INDUSTRIAL CO., LTD. 7560 LINDBERGH DRIVE Gaithersburg, MD 20879 |
| Contact | Joseph F Ludford |
| Correspondent | Joseph F Ludford DIRUI INDUSTRIAL CO., LTD. 7560 LINDBERGH DRIVE Gaithersburg, MD 20879 |
| Product Code | JIO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJQ |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-17 |
| Decision Date | 2004-08-26 |
| Summary: | summary |