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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name atp and creatine kinase (enzymatic), creatine
510(k) Number K992140
Device Name PICCOLO METLYTE 7 REAGENT DISC
Applicant
ABAXIS, INC.
1320 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Applicant Contact LISA MCGRATH
Correspondent
ABAXIS, INC.
1320 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Correspondent Contact LISA MCGRATH
Regulation Number862.1210
Classification Product Code
JLB  
Subsequent Product Codes
CEM   KHS  
Date Received06/24/1999
Decision Date 08/26/1999
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
Recalls CDRH Recalls
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