510(k) K990843

SERUM CROSSLAPS ONE STEP ELISA by Osteometer Biotech A/S — Product Code JMM

K990843 is an FDA 510(k) premarket notification submitted by Osteometer Biotech A/S for the device "SERUM CROSSLAPS ONE STEP ELISA". The FDA issued a decision of Substantially Equivalent on July 9, 1999. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Osteometer Biotech A/S has at least 1 other 510(k) clearance on record.