Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit – Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972)
Description
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) by Healgen Scientific, LLC, an FDA 510(k) cleared clinical toxicology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251972
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit – Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Re... | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 |
Trace the full predicate network for K251972
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.