510(k) K944227

ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER by Medical Laboratory Automation Systems, Inc. — Product Code GKP

K944227 is an FDA 510(k) premarket notification submitted by Medical Laboratory Automation Systems, Inc. for the device "ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER". The FDA issued a decision of Substantially Equivalent on February 3, 1995. 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.