510(k) K011052

OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE by Ostex Intl., Inc. — Product Code JMM

K011052 is an FDA 510(k) premarket notification submitted by Ostex Intl., Inc. for the device "OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE". The FDA issued a decision of Substantially Equivalent on July 30, 2001. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Ostex Intl., Inc. has at least 4 other 510(k) clearances on record.