FDA 510(k) Application Details - K062808

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K062808
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	CATCH INCORPORATED 21031 SE 202ND STREET RENTON, WA 98058 US Other 510(k) Applications for this Company
Contact	Cindy Green 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	09/19/2006
Decision Date	10/13/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review