Healgen URS Test Strips
FDA 510(k) K231045 · Healgen Scientific,, LLC
510(k) numberK231045
Submission
- Device name
- Healgen URS Test Strips
- Applicant
- Healgen Scientific,, LLC
Bellaire, TX, US - Received
- April 12, 2023
- Decision date
- June 16, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJX – Test, Urine Leukocyte
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.7675
- Specialty
- Hematology
Other 510(k)s with product code LJX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063295 | Acon Uti Urinary Tract Infection Test StripsLJX · Traditional | ACON Laboratories, Inc. | 10/12/2007SE |
| K000578 | Serim Leukocyte Esterase Test StripsLJX · Traditional | Serim Research Corp. | 05/05/2000SE |
| K981555 | Diascreen Reagent StripsLJX · Traditional | Chronimed, Inc. | 06/01/1998SE |
| K971976 | Diascreen Reagent StripsLJX · Traditional | Dia-Screen Corp. | 06/17/1997SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | Miles Laboratories, Inc. | 09/11/1987SE |
| K843727 | Leukostix Reagent Strips for UrinalysisLJX · Traditional | Miles Laboratories, Inc. | 01/04/1985SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-TestQYT · Traditional | 04/13/2026SE |
| K253705 | Healgen® Accurate Oral Fluid Drug TestDJC · Traditional | 03/16/2026SE |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestNFW · Traditional | 02/12/2026SE |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 12/23/2025SE |
| K251800 | Healgen® URS Test StripsJMT · Traditional | 12/23/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | 08/15/2025SE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | 12/17/2024SE |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…NGL · Traditional | 05/13/2024SE |
| K232377 | Healgen Rapid COVID-19 Antigen TestQVF · Traditional | 04/19/2024SE |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 04/12/2024SE |
Questions and answers
When was Healgen URS Test Strips cleared by the FDA?
Healgen URS Test Strips (K231045) received a 510(k) decision of Substantially Equivalent on June 16, 2023, 65 days after the submission was received.
What is the product code of K231045?
The FDA product code is LJX – Test, Urine Leukocyte, a Class I (low risk) device regulated under 21 CFR 864.7675.