Cleared Traditional

CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine

K142609 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology
Dec 2014
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K142609 is an FDA 510(k) clearance for the CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine, a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFG), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 18, 2014, 93 days after receiving the submission on September 16, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K142609 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2014
Decision Date December 18, 2014
Days to Decision 93 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3910
Definition Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.

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