FDA 510(k) Application Details - K032608

Device Classification Name	Calibrator, Primary   More FDA Info for this Device
510(K) Number	K032608
Device Name	Calibrator, Primary
Applicant	GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB SCHOENHAUSER STRASSE 73C BERLIN 13158 DE Other 510(k) Applications for this Company
Contact	THOMAS BOCK Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2003
Decision Date	10/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review