K231045 is an FDA 510(k) clearance for the Healgen URS Test Strips. This device is classified as a Test, Urine Leukocyte (Class I - General Controls, product code LJX).
Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on June 16, 2023, 65 days after receiving the submission on April 12, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7675.
| 510(k) Number | K231045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2023 |
| Decision Date | June 16, 2023 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LJX — Test, Urine Leukocyte |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.7675 |