HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL


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 street
bellaire, 
TX 
77401

Applicant Contact yongquan wang
Correspondent
HEALGEN SCIENTIFIC, LLC
5213 maple street
bellaire, 
TX 
77401

Correspodent Contact yongquan wang
Regulation Number 864.6550
Classification Product Code
JIO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIR  
JJB   JMA   JMT   JRE   KQO   LJX  
Date Received 07/13/2011
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