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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colorimetric method, triglycerides
510(k) Number K120664
Device Name PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
Applicant
ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY,  CA  94587
Applicant Contact Dennis M Bleile
Correspondent
ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY,  CA  94587
Correspondent Contact Dennis M Bleile
Regulation Number862.1705
Classification Product Code
JGY  
Date Received03/05/2012
Decision Date 04/24/2012
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
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