510(k) K191534 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, Jul 11, 2019 |
| Received | Jun 10, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191534
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.