Product code JMM
- Device name
- Column Chromatography & Color Development, Hydroxyproline
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1400
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011052 | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | Ostex Intl., Inc. | 2001-07-30 |
| K993706 | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY | Roche Diagnostics Corp. | 2000-07-24 |
| K992997 | OSTEOMARK NTX POC | Metrika, Inc. | 1999-11-09 |
| K990843 | SERUM CROSSLAPS ONE STEP ELISA | Osteometer Biotech A/S | 1999-07-09 |
| K983457 | OSTEOMARK NTX SERUM EIA | Ostex Intl., Inc. | 1999-02-02 |
| K983674 | VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| K972788 | CROSSLAPS ELISA | Devices and Diagnostics Consulting Group | 1998-12-22 |
| K981364 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1998-08-13 |
| K980833 | IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 | Diagnostic Products Corp. | 1998-05-01 |
| K980518 | OSTEOMARK | Ostex Intl., Inc. | 1998-03-06 |
| K974260 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1998-01-26 |
| K972580 | DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-09-22 |
| K971312 | IMMULITE PYRILINKS-D | Diagnostic Products Corp. | 1997-05-27 |
| K963251 | CIBA CORNING ACS;180 DPD ASSAY | Ciba Corning Diagnostics Corp. | 1996-10-15 |
| K961562 | OSTEOMARK | Ostex Intl., Inc. | 1996-07-11 |
| K960171 | ACTIVE CROSSLAPS ELISA | Diagnostic Systems Laboratories, Inc. | 1996-03-28 |
| K952320 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1995-12-29 |
| K952506 | PYRILINKS ASSAY KIT | Metra Biosystems, Inc. | 1995-11-03 |
| K952026 | PYRILINKS POLYCLONAL ASSAY KIT | Metra Biosystems, Inc. | 1995-11-03 |
| K945946 | OSTEOMARK(R) | Ostex Intl., Inc. | 1995-05-08 |
| K770603 | HYPRONOSTICON TM | Organon, Inc. | 1977-09-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00845533002936 | NTx Urine | ZEUS SCIENTIFIC, INC. | 2026-02-18 |
| 00845533002943 | NTx Serum | ZEUS SCIENTIFIC, INC. | 2026-02-18 |
| 00845533002004 | Sebia NTx Serum Test System | ZEUS SCIENTIFIC, INC. | 2025-06-13 |
| 00845533001953 | ZEUS NTx Serum | ZEUS SCIENTIFIC, INC. | 2025-03-21 |
| 05060169695986 | IDS Beta CrossLaps® (CTX-I) | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2024-01-03 |
| 05060169690141 | Urine CrossLaps® (CTX-I) EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2023-06-23 |
| 00845533001878 | ZEUS NTx Urine | ZEUS SCIENTIFIC, INC. | 2023-04-18 |
| 00845533001861 | ZEUS NTx Serum | ZEUS SCIENTIFIC, INC. | 2023-04-18 |
| 07613336171561 | Elecsys Beta-CrossLaps/serum | Roche Diagnostics GmbH | 2021-10-01 |
| 07613336187012 | Elecsys Beta-CrossLaps/serum | Roche Diagnostics GmbH | 2021-10-01 |
| 00630414953281 | IMMULITE® Systems PDP CONTROL Pyrilinks-D | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414954202 | IMMULITE®/IMMULITE® 1000 Systems DPD Pyrilinks-D Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414961859 | IMMULITE® 2000 Systems DPD Pyrlinks-D | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414964416 | IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-D | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 10811877010941 | Osteomark NTx Serum | Alere Scarborough, Inc. | 2020-09-16 |
| 10811877010934 | Osteomark NTx Urine | Alere Scarborough, Inc. | 2020-09-16 |
| 10758750000500 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2020-04-01 |
| 30014613333913 | MicroVue | QUIDEL CORPORATION | 2018-08-30 |
| 30014613333906 | MicroVue | QUIDEL CORPORATION | 2018-08-30 |
| 04015630940141 | Elecsys ?-CrossLaps/serum | Roche Diagnostics GmbH | 2017-04-14 |
| 04015630938902 | Elecsys CrossLapsserum Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630914142 | Elecsys CrossLaps CalSet | Roche Diagnostics GmbH | 2016-09-20 |
| 10758750000517 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 05060169690134 | Serum CrossLaps® (CTX-I) ELISA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2016-04-01 |
| 05060169690158 | Urine BETA CrossLaps® (CTX-I) ELISA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2016-04-01 |
| 05060169690165 | Alpha CrossLaps® (CTX-I) EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2016-04-01 |
| 05060169690172 | Urine CartiLaps ® (CTX-II) EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2016-04-01 |
| 05060169690240 | IDS-iSYS CTX-I (Crosslaps) | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2016-04-01 |