510(k) K993706

ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY by Roche Diagnostics Corp. — Product Code JMM

K993706 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on July 24, 2000. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.