FDA 510(k) Application Details - K972409

Device Classification Name	Analyzer, Chemistry, Centrifugal, For Clinical Use   More FDA Info for this Device
510(K) Number	K972409
Device Name	Analyzer, Chemistry, Centrifugal, For Clinical Use
Applicant	LANDMARK SCIENTIFIC, INC. 12300 TWINBROOK PARKWAY, SUITE 625 ROCKVILLEO, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY Other 510(k) Applications for this Contact
Regulation Number	862.2140   More FDA Info for this Regulation Number
Classification Product Code	JJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/1997
Decision Date	08/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review