FDA 510(k) Application Details - K001687

Device Classification Name	Bilirubin (Total And Unbound) In The Neonate Test System   More FDA Info for this Device
510(K) Number	K001687
Device Name	Bilirubin (Total And Unbound) In The Neonate Test System
Applicant	CHROMATICS COLOR SCIENCES INTL., INC. 16809 BRIARDALE RD. ROCKVILLE, MD 20855 US Other 510(k) Applications for this Company
Contact	THOMAS M TSAKERIS 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	06/01/2000
Decision Date	09/13/2001
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