510(k) K854090

DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT by Diatech, Inc. — Product Code JPA

K854090 is an FDA 510(k) premarket notification submitted by Diatech, Inc. for the device "DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on January 6, 1986. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Diatech, Inc. has at least 10 other 510(k) clearances on record.