The following data is part of a premarket notification filed by Urit Medical Electronic Co., Ltd. with the FDA for Uritest 10g & 11g Urine Reagent Strips And Uritest-50 And Uritest-500b Urine Analyzers.
| Device ID | K082811 |
| 510k Number | K082811 |
| Device Name: | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | URIT MEDICAL ELECTRONIC CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Maria Griffin |
| Correspondent | Maria Griffin URIT MEDICAL ELECTRONIC CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| 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 | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | KQO |
| Subsequent Product Code | KSL |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2009-09-11 |
| Summary: | summary |