The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Enteric Pathogen Nucleic Acid Test ( Ep).
| Device ID | K140083 |
| 510k Number | K140083 |
| Device Name: | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Teresa Raich |
| Correspondent | Teresa Raich NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Product Code | PCH |
| Subsequent Product Code | OOI |
| Subsequent Product Code | PCI |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857573006089 | K140083 | 000 |
| 00857573006065 | K140083 | 000 |
| 00857573006058 | K140083 | 000 |
| 00857573006041 | K140083 | 000 |