510(k) K110675

EASYRA UREA NITROGEN AND CREATININE REAGENTS by Medica Corp. — Product Code CDQ

K110675 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA UREA NITROGEN AND CREATININE REAGENTS". The FDA issued a decision of Substantially Equivalent on April 21, 2011. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Medica Corp. has at least 10 other 510(k) clearances on record.