510(k) K983457
- Device
- OSTEOMARK NTX SERUM EIA
- Applicant
- OSTEX INTL., INC.
- 510(k) number
- K983457
- Product code
- JMM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-02
- Date received
- 1998-09-30
- Regulation
- 862.1400
- Classification name
- Column Chromatography & Color Development, Hydroxyproline
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NANCY J.S. MALLINAK
- Address
- 2203 Airport Way S. Suite 400 Seattle WA US 98134 98134
FDA Registration Numbers#
- 3007111389
- 9610126
- 3006198300
- 1319681
- 3007118747
- 2242436
- 8021924
- 1036362
- 3002806944
- 1528450
Source Documents#
Other 510(k) Records For Product Code JMM #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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