510(k) K945491

SERIM(TM) BICARB PH REAGENT STRIPS by Serim Research Corp. — Product Code MNV

K945491 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM(TM) BICARB PH REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on February 1, 1995. The device falls under product code MNV (Strip, Dialysate Ph Indicator), a Class II device regulated under 21 CFR 876.5820. Serim Research Corp. has at least 10 other 510(k) clearances on record.