The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Respiratory Pathogens Flex Nucleic Acid Test (rp Flex).
| Device ID | K143653 |
| 510k Number | K143653 |
| Device Name: | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Noah Lermer |
| Correspondent | Fran White MDC ASSOCIATES, LLC 180 Cabot Street Beverly, MA 01915 |
| Product Code | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OZE |
| Subsequent Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-23 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857573006324 | K143653 | 000 |
| 00857573006263 | K143653 | 000 |
| 00857573006164 | K143653 | 000 |