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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K110830
Device Name ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
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 Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CJY   JIX   JJY  
Date Received03/25/2011
Decision Date 06/21/2011
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
Recalls CDRH Recalls
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