510(k) K875161

MAT (TM) MICROALBUMIN TEST by Wampole Laboratories — Product Code DCF

K875161 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "MAT (TM) MICROALBUMIN TEST". The FDA issued a decision of Substantially Equivalent on February 17, 1988. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Wampole Laboratories has at least 10 other 510(k) clearances on record.