510(k) K892526

SPQ TM TEST SYSTEM II FOR CRP by Atlantic Antibodies — Product Code DCK

K892526 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ TM TEST SYSTEM II FOR CRP". The FDA issued a decision of Substantially Equivalent on May 9, 1989. 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.