The following data is part of a premarket notification filed by Seegene with the FDA for Seegene Anyplex Ii Hsv-1/2 Assay.
| Device ID | K142156 |
| 510k Number | K142156 |
| Device Name: | SEEGENE ANYPLEX II HSV-1/2 ASSAY |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | SEEGENE 180 Cabot Street Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White MDC ASSOCIATES, LLC 180 Cabot Street 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 | 2014-08-06 |
| Decision Date | 2015-02-13 |
| Summary: | summary |