510(k) K191918 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 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2025 | Remel, Inc Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ Open, Classified |
LRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.