Source document or public record
FDA 510(k) K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
FDA 510(k) index record K201630. Device: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests. Applicant as listed: Assure Tech. (Hangzhou) Co, Ltd.. Decision date: 2021-08-12.
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"device_name": "AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K201630.
Device name: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests. Applicant as listed: Assure Tech. (Hangzhou) Co, Ltd..
Decision date: 2021-08-12. Decision wording: Substantially Equivalent.
Product code: DJG. Regulation: 21 CFR 862.3650. 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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