FDA 510(k) Application Details - K011689

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K011689
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	CATCH, INC. PO BOX 2219 LONGVIEW, WA 98632 US Other 510(k) Applications for this Company
Contact	MARK E LEGAZ 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	05/31/2001
Decision Date	07/25/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review