FDA 510(k) Application Details - K103340

Device Classification Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use   More FDA Info for this Device
510(K) Number	K103340
Device Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant	HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 PLYMOUTH, MA 02360 US Other 510(k) Applications for this Company
Contact	JOHN D BONASERA Other 510(k) Applications for this Contact
Regulation Number	862.2050   More FDA Info for this Regulation Number
Classification Product Code	JQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2010
Decision Date	12/06/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review