FDA 510(k) Applications for Medical Device Product Code "OAI"
(Assay, Enterovirus Nucleic Acid)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K063261 | BIOMERIEUX, INC. | NUCLISENS EASYQ ENTEROVIRUS SYSTEM | 06/23/2008 |
| DEN070004 | CEPHEID | XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 | 03/16/2007 |
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