Catch Incorporated

Medical device manufacturer in Bothell, WA.

2510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K062808Liquid Stable (LS) 2-PART Homocysteine ReagentLPS · Special 10/13/2006SE
K011689Homogeneous Enzymic Homocysteine ReagentLPS · Traditional 07/25/2001SE

Recalls

RecallProductInitiated
Z-0921-2012 Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number…Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had… 06/27/2011Terminated
Z-0448-2009 Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2…A high homocysteine level can be reported as falsely low. 01/18/2007Terminated