510(k) K934210

HEMOLAB PROTEIN C CHROMOGENIC ASSAY by Biomerieux Vitek, Inc. — Product Code GGP

K934210 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "HEMOLAB PROTEIN C CHROMOGENIC ASSAY". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.