Source document or public record

FDA 510(k) K220685 — HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx

FDA 510(k) index record K220685. Device: HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx. Applicant as listed: Qingdao Hightop Biotech Co., Ltd.. Decision date: 2022-05-05.

OtherU.S. Food and Drug Administration (FDA)2022-05-05

Source

"device_name": "HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K220685.

Device name: HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx. Applicant as listed: Qingdao Hightop Biotech Co., Ltd..

Decision date: 2022-05-05. 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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