510(k) K972257

N-ASSAY TIA ANTITHROMBIN III TEST KIT by Crestat Diagnostics, Inc. — Product Code DDQ

K972257 is an FDA 510(k) premarket notification submitted by Crestat Diagnostics, Inc. for the device "N-ASSAY TIA ANTITHROMBIN III TEST KIT". The FDA issued a decision of Substantially Equivalent on October 20, 1997. The device falls under product code DDQ (Antigen, Antiserum, Control, Antithrombin Iii), a Class II device regulated under 21 CFR 864.7060. Crestat Diagnostics, Inc. has at least 10 other 510(k) clearances on record.