FDA 510(k) Application Details - K003597

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K003597
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. LOS ANGELES, CA 90045-5597 US Other 510(k) Applications for this Company
Contact	EDWARD M LEVINE Other 510(k) Applications for this Contact
Regulation Number	862.1377   More FDA Info for this Regulation Number
Classification Product Code	LPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2000
Decision Date	02/05/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review