The following data is part of a premarket notification filed by Indevr, Inc. with the FDA for Fluchip-8g Influenza A+b Assay.
| Device ID | K182513 |
| 510k Number | K182513 |
| Device Name: | FluChip-8G Influenza A+B Assay |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant | InDevR, Inc. 2100 Central Avenue, Suite 106 Boulder, CO 80301 |
| Contact | Erica Dawson |
| Correspondent | Erica Dawson InDevR, Inc. 2100 Central Avenue, Suite 106 Boulder, CO 80301 |
| Product Code | OZE |
| Subsequent Product Code | NSU |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OQW |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-04-22 |