Cleared Traditional

BIOEASY? U-Catch MAX Multi-Drug Test Cup, BIOEASY? U-Catch MAX Multi-Drug Test Cup Rx

K230238 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Toxicology
Mar 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K230238 is an FDA 510(k) clearance for the BIOEASY? U-Catch MAX Multi-Drug Test Cup, BIOEASY? U-Catch MAX Multi-Drug Test Cup Rx, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 31, 2023, 60 days after receiving the submission on January 30, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K230238 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2023
Decision Date March 31, 2023
Days to Decision 60 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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