510(k) K931149

CA-1000 AUTOMATED COAGULATION ANALYZER by Toa Medical Electronics USA, Inc. — Product Code JPA

K931149 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "CA-1000 AUTOMATED COAGULATION ANALYZER". The FDA issued a decision of Substantially Equivalent on November 3, 1993. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.