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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Leak, Blood
510(k) Number K042322
Device Name STERICHEK BLOOD LEAK REAGENT STRIPS
Applicant
Hach Company
23575 County Rd. 106
Elkhart,  IN  46514
Applicant Contact DAVID A MORRIS, PH.D.
Correspondent
Hach Company
23575 County Rd. 106
Elkhart,  IN  46514
Correspondent Contact DAVID A MORRIS, PH.D.
Regulation Number876.5820
Classification Product Code
FJD  
Date Received08/26/2004
Decision Date 12/07/2004
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
Predetermined Change
Control Plan Authorized		 No
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