FJD — Detector, Leak, Blood Class II

FDA Device Classification

Classification Details

Product Code
FJD
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123805reprocessing productsE-Z CHEK BLOOD LEAK TEST STRIPSMarch 20, 2013
K042322hachSTERICHEK BLOOD LEAK REAGENT STRIPSDecember 7, 2004
K012115serim researchSERIM BLOOD LEAK TEST STRIP-2November 30, 2001
K990206serim researchSERIM BLOOD LEAK TEST STRIPApril 21, 1999