510(k) K082141

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 by Biokit, S.A. — Product Code JIT

K082141 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10". The FDA issued a decision of Substantially Equivalent on September 3, 2008. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Biokit, S.A. has at least 10 other 510(k) clearances on record.