K242767 is an FDA 510(k) clearance for the Safecare Urinary Tract Infection Test. This device is classified as a Diazo (colorimetric), Nitrite (urinary, Non-quant) (Class I - General Controls, product code JMT).
Submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 10, 2025, 119 days after receiving the submission on September 13, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1510.
| 510(k) Number | K242767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JMT - Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1510 |