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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number K052925
Device Name SMARTPREP2 CENTRIFUGE SYSTEM
Applicant
HARVEST TECHNOLOGIES, CORP.
40 GRISSOM RD
PLYMOUTH,  MA  02360
Applicant Contact JOHN D BONASERA
Correspondent
HARVEST TECHNOLOGIES, CORP.
40 GRISSOM RD
PLYMOUTH,  MA  02360
Correspondent Contact JOHN D BONASERA
Regulation Number862.2050
Classification Product Code
JQC  
Subsequent Product Code
FMF  
Date Received10/18/2005
Decision Date 01/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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