FluChip-8G Influenza A+B Assay — Indevr, Inc. (510(k) K182513)
FluChip-8G Influenza A+B Assay — Indevr, Inc. (510(k) K182513) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: FluChip-8G Influenza A+B Assay; Applicant: Indevr, Inc.; Clearance track: 510(k).
| Device name | FluChip-8G Influenza A+B Assay |
|---|---|
| Applicant | Indevr, Inc. |
| Clearance track | 510(k) |
| Submission number | K182513 |
| Decision | Substantially Equivalent |
| Decision date | 2019-04-22 |
| Date received | 2018-09-12 |
| Product code | OZE |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | CO, US |
| Source | openFDA device |
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