K182384 is an FDA 510(k) clearance for the ACR LAB Urine Analysis Test System. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on July 26, 2019, 329 days after receiving the submission on August 31, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K182384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2018 |
| Decision Date | July 26, 2019 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFY - Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |