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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood, occult, colorimetric, in urine
510(k) Number K232317
Device Name UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
Applicant
URIT Medical Electronic Co., Ltd.
NO. D-07 Information Industry District, High-Tech Zone,
Guilin, Guangxi 541004, P.R.China
Guilin,  CN 541004
Applicant Contact Jiang Jun
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
14th Floor, 1500# Century Avenue
Shanghai,  CN 200122
Correspondent Contact Dylan Wu
Regulation Number864.6550
Classification Product Code
JIO  
Subsequent Product Codes
CDM   CEN   JFY   JIL   JIN  
JIR   JJB   JMA   JMT   JRE   KQO  
LJX  
Date Received08/03/2023
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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