510(k) K961024

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB by Princeton BioMeditech Corp. — Product Code KTN

K961024 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB". The FDA issued a decision of Substantially Equivalent on February 4, 1997. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.