Detector, Leak, Blood

FDA product code FJD · Class II (moderate risk) · 21 CFR 876.5820 · Gastroenterology, Urology

4510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K123805E-Z Chek Blood Leak Test StripsFJD · Traditional Reprocessing Products Corp03/20/2013SE
K042322Sterichek Blood Leak Reagent StripsFJD · Traditional Hach Company12/07/2004SE
K012115Serim Blood Leak Test STRIP-2FJD · Traditional Serim Research Corp.11/30/2001SE
K990206Serim Blood Leak Test StripFJD · Traditional Serim Research Corp.04/21/1999SE