| OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (K011052) | Ostex Intl., Inc. | 2001-07-30 |
| ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (K993706) | Roche Diagnostics Corp. | 2000-07-24 |
| OSTEOMARK NTX POC (K992997) | Metrika, Inc. | 1999-11-09 |
| SERUM CROSSLAPS ONE STEP ELISA (K990843) | Osteometer Biotech A/S | 1999-07-09 |
| OSTEOMARK NTX SERUM EIA (K983457) | Ostex Intl., Inc. | 1999-02-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS (K983674) | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| CROSSLAPS ELISA (K972788) | Devices and Diagnostics Consulting Group | 1998-12-22 |
| PYRILINKS-D ASSAY KIT (K981364) | Metra Biosystems, Inc. | 1998-08-13 |
| IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (K980833) | Diagnostic Products Corp. | 1998-05-01 |
| OSTEOMARK (K980518) | Ostex Intl., Inc. | 1998-03-06 |
| PYRILINKS-D ASSAY KIT (K974260) | Metra Biosystems, Inc. | 1998-01-26 |
| DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972580) | Bayer Corp. | 1997-09-22 |
| IMMULITE PYRILINKS-D (K971312) | Diagnostic Products Corp. | 1997-05-27 |
| CIBA CORNING ACS;180 DPD ASSAY (K963251) | Ciba Corning Diagnostics Corp. | 1996-10-15 |
| OSTEOMARK (K961562) | Ostex Intl., Inc. | 1996-07-11 |
| ACTIVE CROSSLAPS ELISA (K960171) | Diagnostic Systems Laboratories, Inc. | 1996-03-28 |
| PYRILINKS-D ASSAY KIT (K952320) | Metra Biosystems, Inc. | 1995-12-29 |
| PYRILINKS ASSAY KIT (K952506) | Metra Biosystems, Inc. | 1995-11-03 |
| PYRILINKS POLYCLONAL ASSAY KIT (K952026) | Metra Biosystems, Inc. | 1995-11-03 |
| OSTEOMARK(R) (K945946) | Ostex Intl., Inc. | 1995-05-08 |
| HYPRONOSTICON TM (K770603) | Organon, Inc. | 1977-09-02 |