SERIM HISENSE ULTRA 0.1, PART NUMBER 5167


Device Classification Name

strip, test, reagent, residuals for dialysate, disinfectant

510(k) Number K080712
Device Name SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
Applicant
SERIM RESEARCH CORP.
23565 reedy dr.
elkhart, 
IN 
46514

Applicant Contact patricia rupchock
Correspondent
SERIM RESEARCH CORP.
23565 reedy dr.
elkhart, 
IN 
46514

Correspodent Contact patricia rupchock
Regulation Number 876.5665
Classification Product Code
MSY  
Date Received 03/13/2008
Decision Date 05/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No