K222921 is an FDA 510(k) clearance for the Minuteful-kidney test. This device is classified as a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I - General Controls, product code JIR).
Submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on September 8, 2023, 347 days after receiving the submission on September 26, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K222921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | September 08, 2023 |
| Days to Decision | 347 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIR - Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1645 |