K173327 is an FDA 510(k) clearance for the DIP/U.S. Urine Analysis Test System. This device is classified as a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II - Special Controls, product code JIL).
Submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on July 18, 2018, 271 days after receiving the submission on October 20, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1340.
| 510(k) Number | K173327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2017 |
| Decision Date | July 18, 2018 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIL - Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1340 |