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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 K934592
Device Name EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
Applicant
Abaxis, Inc.
1320 Chesapeake Ter.
Sunnyvale,  CA  94089
Applicant Contact RODGER J RICHEAL
Correspondent
Abaxis, Inc.
1320 Chesapeake Ter.
Sunnyvale,  CA  94089
Correspondent Contact RODGER J RICHEAL
Regulation Number862.2140
Classification Product Code
JJG  
Date Received09/24/1993
Decision Date 04/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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