Osteomark(R)

FDA 510(k) K945946 · Ostex Intl., Inc.

Substantially Equivalent

510(k) numberK945946

Submission

Device name
Osteomark(R)
Applicant
Ostex Intl., Inc.
Seattle, WA, US
Received
December 5, 1994
Decision date
May 8, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JMM – Column Chromatography & Color Development, Hydroxyproline
Device class
Class I (low risk)
Regulation
21 CFR 862.1400
Specialty
Clinical Chemistry

Other 510(k)s with product code JMM

510(k)DeviceApplicantDecision
K011052Osteomark NTX Point of Care Prescription Home UseJMM · Traditional Ostex Intl., Inc.07/30/2001SE
K993706Elecsys Serum B-Crosslaps/Serum ImmunoassayJMM · Traditional Roche Diagnostics Corp.07/24/2000SE
K992997Osteomark NTX PocJMM · Traditional Metrika, Inc.11/09/1999SE
K990843Serum Crosslaps One Step ElisaJMM · Traditional Osteometer Biotech A/S07/09/1999SE
K983457Osteomark NTX Serum EiaJMM · Traditional Ostex Intl., Inc.02/02/1999SE
K983674Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX ControlsJMM · Traditional Ortho-Clinical Diagnostics, Inc.01/29/1999SE
K972788Crosslaps ElisaJMM · Traditional Devices and Diagnostics Consulting Group12/22/1998SE
K981364Pyrilinks-D Assay KitJMM · Traditional Metra Biosystems, Inc.08/13/1998SE
K980833Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5JMM · Traditional Diagnostic Products Corp.05/01/1998SE
K980518OsteomarkJMM · Traditional Ostex Intl., Inc.03/06/1998SE

More from Ostex Intl., Inc.

510(k)DeviceDecision
K011052Osteomark NTX Point of Care Prescription Home UseJMM · Traditional 07/30/2001SE
K983457Osteomark NTX Serum EiaJMM · Traditional 02/02/1999SE
K980518OsteomarkJMM · Traditional 03/06/1998SE
K961562OsteomarkJMM · Traditional 07/11/1996SE

Questions and answers

When was Osteomark(R) cleared by the FDA?

Osteomark(R) (K945946) received a 510(k) decision of Substantially Equivalent on May 8, 1995, 154 days after the submission was received.

What is the product code of K945946?

The FDA product code is JMM – Column Chromatography & Color Development, Hydroxyproline, a Class I (low risk) device regulated under 21 CFR 862.1400.