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 |