510(k) K854546

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

K854546 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "MICROSAMPLE COAGULATION ANALYSER MODEL 110P". The FDA issued a decision of Substantially Equivalent on January 7, 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.