Cleared Traditional

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

K201630 · Assure Tech. (Hangzhou) Co, Ltd. · Toxicology
Aug 2021
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K201630 is an FDA 510(k) clearance for the AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 12, 2021, 422 days after receiving the submission on June 16, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K201630 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2020
Decision Date August 12, 2021
Days to Decision 422 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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