The following data is part of a premarket notification filed by Biohelix Corporation with the FDA for Isoamp Hsv Assay.
| Device ID | K111951 |
| 510k Number | K111951 |
| Device Name: | ISOAMP HSV ASSAY |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | BIOHELIX CORPORATION 32 TOZER RD Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White BIOHELIX CORPORATION 32 TOZER RD Beverly, MA 01915 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2011-09-27 |
| Summary: | summary |