Submission Details
| 510(k) Number | K231045 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Healgen URS Test Strips
Jun 2023
Decision
65d
Days
Class 1
Risk
About This 510(k) Submission
K231045 is an FDA 510(k) clearance for the Healgen URS Test Strips, 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 review panel. Regulated under 21 CFR 864.7675.
Device Classification
| Product Code | LJX — Test, Urine Leukocyte |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.7675 |
Manufacturer
Similar Devices — LJX Test, Urine Leukocyte
K063295 · ACON Laboratories, Inc.
· Oct 2007
K000578 · Serim Research Corp.
· May 2000
K981555 · Chronimed, Inc.
· Jun 1998
K971976 · Dia-Screen Corp.
· Jun 1997
K873304 · Miles Laboratories, Inc.
· Sep 1987
K843727 · Miles Laboratories, Inc.
· Jan 1985
More from Healgen Scientific, LLC
View all
K252523
· NFW · Feb 2026
K251800
· JMT · Dec 2025
K253567
· NGL · Dec 2025
K251972
· DJG · Aug 2025
K243365
· NGL · Dec 2024