FDA 510(k) Application Details - K965036

Device Classification Name	Osmometer For Clinical Use   More FDA Info for this Device
510(K) Number	K965036
Device Name	Osmometer For Clinical Use
Applicant	ADVANCED INSTRUMENTS, INC. TWO TECHNOLOGY WAY NORWOOD, MA 02062 US Other 510(k) Applications for this Company
Contact	DOUGLAS GUERETTE Other 510(k) Applications for this Contact
Regulation Number	862.2730   More FDA Info for this Regulation Number
Classification Product Code	JJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/1996
Decision Date	02/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review