FDA Product Code
FDA Product Code JMM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1400
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K011052 | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | Ostex Intl., Inc. | 2001-07-30 | Traditional | PDF ↗ |
| K993706 | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY | Roche Diagnostics Corp. | 2000-07-24 | Traditional | PDF ↗ |
| K992997 | OSTEOMARK NTX POC | Metrika, Inc. | 1999-11-09 | Traditional | PDF ↗ |
| K990843 | SERUM CROSSLAPS ONE STEP ELISA | Osteometer Biotech A/S | 1999-07-09 | Traditional | PDF ↗ |
| K983457 | OSTEOMARK NTX SERUM EIA | Ostex Intl., Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K983674 | VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K972788 | CROSSLAPS ELISA | Devices and Diagnostics Consulting Group | 1998-12-22 | Traditional | PDF ↗ |
| K981364 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K980833 | IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 | Diagnostic Products Corp. | 1998-05-01 | Traditional | PDF ↗ |
| K980518 | OSTEOMARK | Ostex Intl., Inc. | 1998-03-06 | Traditional | PDF ↗ |
| K974260 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1998-01-26 | Traditional | PDF ↗ |
| K972580 | DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-09-22 | Traditional | PDF ↗ |
| K971312 | IMMULITE PYRILINKS-D | Diagnostic Products Corp. | 1997-05-27 | Traditional | PDF ↗ |
| K963251 | CIBA CORNING ACS;180 DPD ASSAY | Ciba Corning Diagnostics Corp. | 1996-10-15 | Traditional | PDF ↗ |
| K961562 | OSTEOMARK | Ostex Intl., Inc. | 1996-07-11 | Traditional | PDF ↗ |
| K960171 | ACTIVE CROSSLAPS ELISA | Diagnostic Systems Laboratories, Inc. | 1996-03-28 | Traditional | PDF ↗ |
| K952320 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1995-12-29 | Traditional | PDF ↗ |
| K952506 | PYRILINKS ASSAY KIT | Metra Biosystems, Inc. | 1995-11-03 | Traditional | PDF ↗ |
| K952026 | PYRILINKS POLYCLONAL ASSAY KIT | Metra Biosystems, Inc. | 1995-11-03 | Traditional | PDF ↗ |
| K945946 | OSTEOMARK(R) | Ostex Intl., Inc. | 1995-05-08 | Traditional | PDF ↗ |
| K770603 | HYPRONOSTICON TM | Organon, Inc. | 1977-09-02 | Traditional | PDF ↗ |
Product code JMM · Class I · Clinical Chemistry. Data: openFDA.