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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 K111999
Device Name HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
Applicant
Healgen Scientific, LLC
5213 Maple St.
Bellaire,  TX  77401
Applicant Contact YONGQUAN WANG
Correspondent
Healgen Scientific, LLC
5213 Maple St.
Bellaire,  TX  77401
Correspondent Contact YONGQUAN WANG
Regulation Number864.6550
Classification Product Code
JIO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIR  
JJB   JMA   JMT   JRE   KQO   LJX  
Date Received07/13/2011
Decision Date 04/17/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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