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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry, centrifugal, for clinical use
510(k) Number K942782
Device Name PICCOLO(TM)
Applicant
ABAXIS, INC.
1320 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Applicant Contact RODGER J RICHEAL
Correspondent
ABAXIS, INC.
1320 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Correspondent Contact RODGER J RICHEAL
Regulation Number862.2140
Classification Product Code
JJG  
Subsequent Product Codes
CDN   CEJ   CEK   CGA   CGX  
CIG   CIT   CJW  
Date Received06/13/1994
Decision Date 03/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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