FDA 510(k) Application Details - K994148

Device Classification Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use   More FDA Info for this Device
510(K) Number	K994148
Device Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant	IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. PALM BEACH GARDENS, FL 33410 US Other 510(k) Applications for this Company
Contact	WILLIAM G CONETY 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	12/08/1999
Decision Date	02/01/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review