510(k) K884534

PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER by Pall Biomedical Products Co. — Product Code JPA

K884534 is an FDA 510(k) premarket notification submitted by Pall Biomedical Products Co. for the device "PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Pall Biomedical Products Co. has at least 10 other 510(k) clearances on record.