FDA 510(k) Application Details - K993132

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K993132
Device Name	Calibrator, Secondary
Applicant	GENZYME CORP. 500 KENDALL STREET CAMBRIDGE, MA 02142-1562 US Other 510(k) Applications for this Company
Contact	BARBARA PIZZA Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/1999
Decision Date	10/04/1999
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