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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 K023639
Device Name PICCOLO TRIGLYCERIDES 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 Received10/30/2002
Decision Date 01/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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