510(k) K220801 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
| Applicant | Abbott Diagnostics Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jun 24, 2022 |
| Received | Mar 18, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220801
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.