510(k) K922201

COAMATE PROTEIN C CHROMOGENIC ASSAY by Chromogenix AB — Product Code GGP

K922201 is an FDA 510(k) premarket notification submitted by Chromogenix AB for the device "COAMATE PROTEIN C CHROMOGENIC ASSAY". The FDA issued a decision of Substantially Equivalent on December 7, 1992. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Chromogenix AB has at least 3 other 510(k) clearances on record.