Product Code: JMM FDA class 1 21 CFR 862.1400

Column Chromatography & Color Development, Hydroxyproline

Clinical Chemistry

This device is a clinical chemistry reagent system using column chromatography followed by colorimetric development to measure hydroxyproline in patient specimens such as urine, used as a marker of collagen turnover and bone resorption relevant to metabolic bone diseases, Paget disease, and growth disorders. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JMM, regulated under 21 CFR 862.1400, and assigned to the Clinical Chemistry medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JMM in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JMM
Device Class: FDA class 1
Regulation Number: 862.1400
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011052	OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE	Jul 30, 2001	Substantially Equivalent	Ostex Intl., Inc.
K993706	ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY	Jul 24, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K992997	OSTEOMARK NTX POC	Nov 09, 1999	Substantially Equivalent	Metrika, Inc.
K990843	SERUM CROSSLAPS ONE STEP ELISA	Jul 09, 1999	Substantially Equivalent	Osteometer Biotech A/S
K983457	OSTEOMARK NTX SERUM EIA	Feb 02, 1999	Substantially Equivalent	Ostex Intl., Inc.
K983674	VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS	Jan 29, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K972788	CROSSLAPS ELISA	Dec 22, 1998	Substantially Equivalent	Devices and Diagnostics Consulting Group
K981364	PYRILINKS-D ASSAY KIT	Aug 13, 1998	Substantially Equivalent	Metra Biosystems, Inc.
K980833	IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5	May 01, 1998	Substantially Equivalent	Diagnostic Products Corp.
K980518	OSTEOMARK	Mar 06, 1998	Substantially Equivalent	Ostex Intl., Inc.
K974260	PYRILINKS-D ASSAY KIT	Jan 26, 1998	Substantially Equivalent	Metra Biosystems, Inc.
K972580	DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	Sep 22, 1997	Substantially Equivalent	Bayer Corp.
K971312	IMMULITE PYRILINKS-D	May 27, 1997	Substantially Equivalent	Diagnostic Products Corp.
K963251	CIBA CORNING ACS;180 DPD ASSAY	Oct 15, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K961562	OSTEOMARK	Jul 11, 1996	Substantially Equivalent	Ostex Intl., Inc.
K960171	ACTIVE CROSSLAPS ELISA	Mar 28, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K952320	PYRILINKS-D ASSAY KIT	Dec 29, 1995	Substantially Equivalent	Metra Biosystems, Inc.
K952506	PYRILINKS ASSAY KIT	Nov 03, 1995	Substantially Equivalent	Metra Biosystems, Inc.
K952026	PYRILINKS POLYCLONAL ASSAY KIT	Nov 03, 1995	Substantially Equivalent	Metra Biosystems, Inc.
K945946	OSTEOMARK(R)	May 08, 1995	Substantially Equivalent	Ostex Intl., Inc.
K770603	HYPRONOSTICON TM	Sep 02, 1977	Substantially Equivalent	Organon, Inc.