510(k) K962664

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER by Medical Laboratory Automation Systems, Inc. — Product Code GKP

K962664 is an FDA 510(k) premarket notification submitted by Medical Laboratory Automation Systems, Inc. for the device "ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER". The FDA issued a decision of Substantially Equivalent on September 10, 1996. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Medical Laboratory Automation Systems, Inc. has at least 10 other 510(k) clearances on record.