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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K993211
Device Name PICCOLO SODIUM TEST SYSTEM
Applicant
Abaxis, Inc.
1320 Chesapeake Ter.
Sunnyvale,  CA  94089
Applicant Contact LISA MCGRATH
Correspondent
Abaxis, Inc.
1320 Chesapeake Ter.
Sunnyvale,  CA  94089
Correspondent Contact LISA MCGRATH
Regulation Number862.1665
Classification Product Code
JGS  
Date Received09/24/1999
Decision Date 10/25/1999
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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