Healgen Scientific,, LLC: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Healgen Scientific,, LLC” (first 2012, latest 2026), across 18 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 101 days, against 134 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 279 |
| 2013 | 1 | 128 |
| 2014 | 3 | 62 |
| 2015 | 7 | 56 |
| 2016 | 1 | 159 |
| 2017 | 1 | 216 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 210 |
| 2023 | 2 | 113 |
| 2024 | 4 | 42 |
| 2025 | 3 | 50 |
| 2026 | 3 | 112 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Healgen Scientific,, LLC took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | 4 | 4 |
| NGL | Test, Opiates, Over The Counter | 4 | 4 |
| DJG | Enzyme Immunoassay, Opiates | 3 | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
| JIO | Blood, Occult, Colorimetric, In Urine | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Toxicology (20)
- Microbiology (3)
- Clinical Chemistry (2)
- Hematology (2)
Most recent Healgen Scientific,, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | QYT | 2026-04-13 | 90 |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | DJC | 2026-03-16 | 112 |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | NFW | 2026-02-12 | 185 |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | 2025-12-23 | 36 |
| K251800 | Healgen® URS Test Strips | JMT | 2025-12-23 | 194 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | DJG | 2025-08-15 | 50 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | NGL | 2024-12-17 | 49 |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | NGL | 2024-05-13 | 35 |
| K232377 | Healgen Rapid COVID-19 Antigen Test | QVF | 2024-04-19 | 255 |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | 2024-04-12 | 31 |
17 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-08-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Healgen (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Healgen Scientific,, LLC?
FDA lists 27 510(k) clearances under the applicant name “Healgen Scientific,, LLC” (first 2012, latest 2026), across 18 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Healgen Scientific,, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healgen Scientific,, LLC is 90 days. Since 2017: 101 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Healgen Scientific,, LLC?
The most frequent FDA product codes under this applicant name are JXM (Enzyme Immunoassay, Benzodiazepine, 4); NGL (Test, Opiates, Over The Counter, 4); DJG (Enzyme Immunoassay, Opiates, 3).
Next steps
- See all 27 Healgen Scientific,, LLC clearances with predicates and recalls
- Run predicate analysis for product code JXM, Healgen Scientific,, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.