Submission Details
| 510(k) Number | K251800 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Healgen? URS Test Strips
Dec 2025
Decision
194d
Days
Class 1
Risk
About This 510(k) Submission
K251800 is an FDA 510(k) clearance for the Healgen? URS Test Strips, a Diazo (colorimetric), Nitrite (urinary, Non-quant) (Class I — General Controls, product code JMT), submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on December 23, 2025, 194 days after receiving the submission on June 12, 2025. 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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