FDA 510(k) Application Details - K061549

Device Classification Name	Chromatographic Separation, Lecithin/Sphingomyelin Ratio   More FDA Info for this Device
510(K) Number	K061549
Device Name	Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Applicant	IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	WENDELL LEE, PHARM. D Other 510(k) Applications for this Contact
Regulation Number	862.1455   More FDA Info for this Regulation Number
Classification Product Code	JHG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2006
Decision Date	10/18/2006
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