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FDA 510(k) Applications for Medical Device Product Code "MVJ"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K072358 | Bio-Rad Laboratories | BIOPLEX VASCULITIS KIT | 10/31/2007 |
K991890 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | 08/09/1999 |
K984336 | INOVA DIAGNOSTICS, INC. | QUANTA LITE GBM ELISA | 02/08/1999 |
K011348 | SCIMEDX CORP. | PHASE II GBM IGG ANTIBODY EIA TEST | 06/25/2001 |
K984619 | THE BINDING SITE, LTD. | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | 02/23/1999 |
K071219 | ZEUS SCIENTIFIC, INC. | ATHENA MULTI-LYTE GBM TEST SYSTEM | 12/06/2007 |