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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K112834
Device Name MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
Applicant
Verichem Laboratories, Inc.
90 Narragansett Ave.
Providence,  RI  02907
Applicant Contact ANTHONY JAMES DIMONTE
Correspondent
Verichem Laboratories, Inc.
90 Narragansett Ave.
Providence,  RI  02907
Correspondent Contact ANTHONY JAMES DIMONTE
Regulation Number862.1150
Classification Product Code
JIX  
Date Received09/28/2011
Decision Date 03/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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