510(k) K983460

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER by American Bioproducts Co. — Product Code JPA

K983460 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "STAR AUTOMATED MULTI-PARAMETRIC ANALYZER". The FDA issued a decision of Substantially Equivalent on November 12, 1998. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. American Bioproducts Co. has at least 10 other 510(k) clearances on record.