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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K130200
Device Name PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
Applicant
Abaxis, Inc.
3240 Whipple Rd.
Union City,  CA  94587
Applicant Contact DENNIS M BLEILE, PHD
Correspondent
Abaxis, Inc.
3240 Whipple Rd.
Union City,  CA  94587
Correspondent Contact DENNIS M BLEILE, PHD
Regulation Number862.1175
Classification Product Code
CHH  
Date Received01/28/2013
Decision Date 02/15/2013
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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