FDA 510(k) Application Details - K971508

Device Classification Name	Cells, Animal And Human, Cultured   More FDA Info for this Device
510(K) Number	K971508
Device Name	Cells, Animal And Human, Cultured
Applicant	BIO-WHITTAKER, INC., A CAMBREX CO. 8830 BIGGS FORD RD. WALKERSVILLE, MD 21793-8415 US Other 510(k) Applications for this Company
Contact	LEIF E OLSEN Other 510(k) Applications for this Contact
Regulation Number	864.2280   More FDA Info for this Regulation Number
Classification Product Code	KIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/1997
Decision Date	09/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review