Panels › Clinical Chemistry › Product code JMM · Class 1
Column Chromatography & Color Development, Hydroxyproline
Regulation 862.1400
0510(k)s in 12 months (21 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in JMM
| Company | 510(k)s | Recalls |
|---|---|---|
| Metra Biosystems, Inc. | 5 | 0 |
| Ostex Intl., Inc. | 5 | 0 |
| Diagnostic Products Corp. | 2 | 0 |
| Bayer Corp. | 1 | 0 |
| Ciba Corning Diagnostics Corp. | 1 | 0 |
| Devices and Diagnostics Consulting Group | 1 | 0 |
| Diagnostic Systems Laboratories, Inc. | 1 | 0 |
| Immunodiagnostics Systems Ltd | 0 | 1 |
| Metrika, Inc. | 1 | 0 |
| Organon, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2001 | K011052 | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE Ostex Intl., Inc. | JMM |
| Jul 24, 2000 | K993706 | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY Roche Diagnostics Corp. | JMM |
| Nov 9, 1999 | K992997 | OSTEOMARK NTX POC Metrika, Inc. | JMM |
| Jul 9, 1999 | K990843 | SERUM CROSSLAPS ONE STEP ELISA Osteometer Biotech A/S, DK | JMM |
| Feb 2, 1999 | K983457 | OSTEOMARK NTX SERUM EIA Ostex Intl., Inc. | JMM |
| Jan 29, 1999 | K983674 | VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS Ortho-Clinical Diagnostics, Inc. | JMM |
| Dec 22, 1998 | K972788 | CROSSLAPS ELISA Devices and Diagnostics Consulting Group | JMM |
| Aug 13, 1998 | K981364 | PYRILINKS-D ASSAY KIT Metra Biosystems, Inc. | JMM |
| May 1, 1998 | K980833 | IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 Diagnostic Products Corp. | JMM |
| Mar 6, 1998 | K980518 | OSTEOMARK Ostex Intl., Inc. | JMM |
| Jan 26, 1998 | K974260 | PYRILINKS-D ASSAY KIT Metra Biosystems, Inc. | JMM |
| Sep 22, 1997 | K972580 | DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. | JMM |
| May 27, 1997 | K971312 | IMMULITE PYRILINKS-D Diagnostic Products Corp. | JMM |
| Oct 15, 1996 | K963251 | CIBA CORNING ACS;180 DPD ASSAY Ciba Corning Diagnostics Corp. | JMM |
| Jul 11, 1996 | K961562 | OSTEOMARK Ostex Intl., Inc. | JMM |
| Mar 28, 1996 | K960171 | ACTIVE CROSSLAPS ELISA Diagnostic Systems Laboratories, Inc. | JMM |
| Dec 29, 1995 | K952320 | PYRILINKS-D ASSAY KIT Metra Biosystems, Inc. | JMM |
| Nov 3, 1995 | K952506 | PYRILINKS ASSAY KIT Metra Biosystems, Inc. | JMM |
| Nov 3, 1995 | K952026 | PYRILINKS POLYCLONAL ASSAY KIT Metra Biosystems, Inc. | JMM |
| May 8, 1995 | K945946 | OSTEOMARK(R) Ostex Intl., Inc. | JMM |
| Sep 2, 1977 | K770603 | HYPRONOSTICON TM Organon, Inc. | JMM |
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