The following data is part of a premarket notification filed by Serosep, Ltd. with the FDA for Entericbio Dx Assay.
| Device ID | K182703 |
| 510k Number | K182703 |
| Device Name: | EntericBio Dx Assay |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Serosep, Ltd. Annacotty Business Park Annacotty, IE V94 Ff83 |
| Contact | David Clancy |
| Correspondent | Fran White MDC Associates, LLC 180 Cabot Street Beverly, MA 01915 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-06-19 |