Submission Details
| 510(k) Number | K242767 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Safecare Urinary Tract Infection Test
Jan 2025
Decision
119d
Days
Class 1
Risk
About This 510(k) Submission
K242767 is an FDA 510(k) clearance for the Safecare Urinary Tract Infection Test, 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 review panel. Regulated under 21 CFR 862.1510.
Device Classification
| Product Code | JMT — Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1510 |
Manufacturer
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