510(k) K961579

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER by American Bioproducts Co. — Product Code GKP

K961579 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER". The FDA issued a decision of Substantially Equivalent on July 10, 1996. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. American Bioproducts Co. has at least 10 other 510(k) clearances on record.