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 |