510(k) K171792 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | Jun 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2026 | Abbott Diagnostics Scarborough, Inc. Product Name: ID NOW" Influenza A & B 2
Model/Catalog Number: 427-000
Software Version: Not Applicable
Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique
Component: Open, Classified |
OZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.