510(k) K864534

ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER by Medical Laboratory Automation Systems, Inc. — Product Code JPA

K864534 is an FDA 510(k) premarket notification submitted by Medical Laboratory Automation Systems, Inc. for the device "ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Medical Laboratory Automation Systems, Inc. has at least 10 other 510(k) clearances on record.