510(k) K232775 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
ID NOW Influenza A & B 2
| Applicant | Abbott Diagnostics Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Oct 10, 2023 |
| Received | Sep 11, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic A Open, Classified |
OZE | None listed |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic A Open, Classified |
OZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.