FDA 510(k) Application Details - K994438

Device Classification Name	Bilirubin (Total And Unbound) In The Neonate Test System   More FDA Info for this Device
510(K) Number	K994438
Device Name	Bilirubin (Total And Unbound) In The Neonate Test System
Applicant	SPECTRX, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	JAMES R VEALE 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	12/30/1999
Decision Date	02/04/2000
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