510(k) K840114

COAGULATION FACTOR DEFICIENT PLASMA by Medical Specialties Laboratories — Product Code GGP

K840114 is an FDA 510(k) premarket notification submitted by Medical Specialties Laboratories for the device "COAGULATION FACTOR DEFICIENT PLASMA". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Medical Specialties Laboratories has at least 4 other 510(k) clearances on record.