K191918 is an FDA 510(k) clearance for the Thermo Scientific Sensititre ARIS HiQ System. This device is classified as a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II - Special Controls, product code LRG).
Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on November 6, 2019, 111 days after receiving the submission on July 18, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K191918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2019 |
| Decision Date | November 06, 2019 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |