Healgen Scientific Llc
FDA Regulatory Profile
Healgen Scientific Llc appears in FDA public data with 1 recall, 27 510(k) clearances, 10 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-3303-2024, Class II) was initiated on August 22, 2024. Its most recent 510(k) clearance was granted on April 13, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 27
- Inspections
- 10
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3303-2024 | Class II | Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test st | August 22, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | April 13, 2026 |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | March 16, 2026 |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | February 12, 2026 |
| K251800 | Healgen® URS Test Strips | December 23, 2025 |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | December 23, 2025 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunoflu | August 15, 2025 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | December 17, 2024 |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Casset | May 13, 2024 |
| K232377 | Healgen Rapid COVID-19 Antigen Test | April 19, 2024 |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | April 12, 2024 |
| K231045 | Healgen URS Test Strips | June 16, 2023 |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | March 17, 2023 |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | March 16, 2022 |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | August 2, 2017 |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | May 23, 2016 |
| K152269 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cu | September 9, 2015 |
| K151348 | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Casse | August 18, 2015 |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | August 13, 2015 |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | May 13, 2015 |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Casse | April 24, 2015 |