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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K110780
Device Name ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
Applicant
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Codes
JIX   JJY  
Date Received03/21/2011
Decision Date 10/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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
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