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FDA 510(k) K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup

FDA 510(k) index record K243996. Device: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup. Applicant as listed: Assure Tech., LLC. Decision date: 2025-02-07.

OtherU.S. Food and Drug Administration (FDA)2025-02-07

Fuente

"device_name": "AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-25

Disclaimer

professional use

References

FDA 510(k) public index record K243996.

Device name: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup. Applicant as listed: Assure Tech., LLC.

Decision date: 2025-02-07. Decision wording: Substantially Equivalent.

Product code: NFT. Regulation: 21 CFR 862.3100. Medical specialty: Clinical Toxicology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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