The following data is part of a premarket notification filed by Eragen Biosciences, Inc. with the FDA for Multicode-rtx Herpes Simplex Virus 1 & 2 Kit.
| Device ID | K111527 |
| 510k Number | K111527 |
| Device Name: | MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | ERAGEN BIOSCIENCES, INC. 918 Deming Way, Suite 201 Madison, WI 53717 -1944 |
| Contact | David Lim |
| Correspondent | David Lim ERAGEN BIOSCIENCES, INC. 918 Deming Way, Suite 201 Madison, WI 53717 -1944 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-08-03 |