K210069 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 July 6, 2022, 541 days after receiving the submission on January 11, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K210069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2021 |
| Decision Date | July 06, 2022 |
| Days to Decision | 541 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 |