510(k) K161375 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Aug 18, 2016 |
| Received | May 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW RSV 24T
Product Name: ID NOW RSV 24T
Model/Catalog Number: 435-000
Software Version: N/A
Product Description: Respiratory virus panel nucleic acid assay system
Component: No Open, Classified |
OCC | None listed |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW RSV 24T
Product Name: ID NOW RSV 24T
Model/Catalog Number: 435-000
Software Version: N/A
Product Description: Respiratory virus panel nucleic acid assay system
Component: No Open, Classified |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.