GLUTARTEST 1 REAGENT STRIP


the company

Device Classification Name

strip, test, reagent, residuals for dialysate, disinfectant

510(k) Number K002011
Device Name GLUTARTEST 1 REAGENT STRIP
Original Applicant
INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
2931 moose trail
elkhart, 
IN 
46514

Original Contact wen h wu
Regulation Number 876.5665
Classification Product Code
MSY  
Subsequent Product Code
LIF  
Date Received 07/03/2000
Decision Date 01/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No