510(k) K981364

PYRILINKS-D ASSAY KIT by Metra Biosystems, Inc. — Product Code JMM

K981364 is an FDA 510(k) premarket notification submitted by Metra Biosystems, Inc. for the device "PYRILINKS-D ASSAY KIT". The FDA issued a decision of Substantially Equivalent on August 13, 1998. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Metra Biosystems, Inc. has at least 6 other 510(k) clearances on record.