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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K022312
Device Name PICCOLO PHOSPHORUS TEST SYSTEM
Applicant
ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY,  CA  94587
Applicant Contact ROBERT MILDER
Correspondent
ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY,  CA  94587
Correspondent Contact ROBERT MILDER
Regulation Number862.1580
Classification Product Code
CEO  
Date Received07/17/2002
Decision Date 09/05/2002
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
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