510(k) K860342

MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP by Bio/Data Corp. — Product Code JPA

K860342 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Bio/Data Corp. has at least 10 other 510(k) clearances on record.