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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(k) Number K051108
Device Name PICCOLO LACTATE DEPHYDROGENASE 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 Number862.1440
Classification Product Code
CFJ  
Date Received05/02/2005
Decision Date 07/08/2005
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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