510(k) K851842

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN by Atlantic Antibodies — Product Code DCK

K851842 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN". The FDA issued a decision of Substantially Equivalent on June 5, 1985. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Atlantic Antibodies has at least 10 other 510(k) clearances on record.