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FDA 510(k) Applications for Medical Device Product Code "NPR"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K223046 | Cepheid« | Xpert« FII & FV | 02/15/2023 |
K100943 | HOLOGIC, INC. | INVADER FACTOR II | 06/02/2011 |
K033612 | ROCHE DIAGNOSTICS CORP. | FACTOR II (PROTHROMBIN) G20210A KIT | 12/18/2003 |
K172913 | Roche Molecular Systems, Inc. | cobas Factor II and Factor V Test | 01/12/2018 |