510(k) K002177

THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES by Haemoscope Corp. — Product Code JPA

K002177 is an FDA 510(k) premarket notification submitted by Haemoscope Corp. for the device "THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES". The FDA issued a decision of Substantially Equivalent on September 14, 2000. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Haemoscope Corp. has at least 6 other 510(k) clearances on record.