K140717 is an FDA 510(k) clearance for the CLINITEK NOVUS. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on November 17, 2014, 242 days after receiving the submission on March 20, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K140717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2014 |
| Decision Date | November 17, 2014 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KQO — Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |