Cleared Traditional

CR3 Keyless Split Sample Cup Secobarbital- Methadone

K143535 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry
Jan 2015
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K143535 is an FDA 510(k) clearance for the CR3 Keyless Split Sample Cup Secobarbital- Methadone, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on January 13, 2015, 29 days after receiving the submission on December 15, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K143535 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2014
Decision Date January 13, 2015
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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