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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2013 | Roche Diagnostics Operations, Inc. B-CrossLaps/serum (B-CTx in serum)
REF 11972308 160
100 tests
Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid i Terminated |
JMM | K993706 |
| Oct 10, 2012 | Immunodiagnostics Systems Ltd IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles.
The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantificat Terminated |
JMM | None listed |
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