510(k) K191914 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Thermo Scientific Sensititre ARIS HiQ System
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Nov 6, 2019 |
| Received | Jul 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191914
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.