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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K133003
Device Name RIGHTEST CONTROL SOLUTION
Applicant
Bionime Corporation
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
Bionime Corporation
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/25/2013
Decision Date 10/24/2013
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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