Panels › Immunology › Product code MVJ · Class 2
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Regulation 866.5660
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MVJ
| Company | 510(k)s | Recalls |
|---|---|---|
| The Binding Site, Ltd. | 1 | 0 |
| Bio-Rad Laboratories | 1 | 0 |
| Cogent Diagnotics , Ltd. | 1 | 0 |
| Inova Diagnostics, Inc. | 1 | 0 |
| Scimedx Corp. | 1 | 0 |
| Zeus Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 6, 2007 | K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM Zeus Scientific, Inc. | MVJ |
| Oct 31, 2007 | K072358 | BIOPLEX VASCULITIS KIT Bio-Rad Laboratories | MVJ |
| Jun 25, 2001 | K011348 | PHASE II GBM IGG ANTIBODY EIA TEST Scimedx Corp. | MVJ |
| Aug 9, 1999 | K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA Cogent Diagnotics , Ltd., GB | MVJ |
| Feb 23, 1999 | K984619 | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. | MVJ |
| Feb 8, 1999 | K984336 | QUANTA LITE GBM ELISA Inova Diagnostics, Inc. | MVJ |
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