The following data is part of a premarket notification filed by Argene Sa with the FDA for Adenovirus R-gene Us.
| Device ID | K121942 |
| 510k Number | K121942 |
| Device Name: | ADENOVIRUS R-GENE US |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | ARGENE SA PARC TECHNOLOGIQUE DELTA SUD Varilhes, FR 09120 |
| Contact | Eric Brisson |
| Correspondent | Eric Brisson ARGENE SA PARC TECHNOLOGIQUE DELTA SUD Varilhes, FR 09120 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2013-02-08 |
| Summary: | summary |