FDA 510(k) Application Details - K980646

Device Classification Name	Bilirubin (Total And Unbound) In The Neonate Test System   More FDA Info for this Device
510(K) Number	K980646
Device Name	Bilirubin (Total And Unbound) In The Neonate Test System
Applicant	INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. LEXINGTON, MA 02173 US Other 510(k) Applications for this Company
Contact	CAROL MARBLE Other 510(k) Applications for this Contact
Regulation Number	862.1113   More FDA Info for this Regulation Number
Classification Product Code	MQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/1998
Decision Date	05/06/1998
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