510(k) K141689

FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit by Qualigen, Inc. — Product Code DCK

K141689 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit". The FDA issued a decision of Substantially Equivalent on January 7, 2015. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Qualigen, Inc. has at least 10 other 510(k) clearances on record.