The following data is part of a premarket notification filed by Eragen Biosciences with the FDA for Multicode - Rtx Herpes Simplex Virus 1 And 2 Kit, Model 3711.
| Device ID | K100336 |
| 510k Number | K100336 |
| Device Name: | MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | ERAGEN BIOSCIENCES 918 DEMING WAY SUITE 201 Madison, WI 53717 |
| Contact | Randal Vader |
| Correspondent | Randal Vader ERAGEN BIOSCIENCES 918 DEMING WAY SUITE 201 Madison, WI 53717 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-05 |
| Decision Date | 2010-05-12 |
| Summary: | summary |