Cleared Traditional

LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)

K141055 · Lin-Zhi International, Inc. · Toxicology
Jun 2014
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K141055 is an FDA 510(k) clearance for the LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML), a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 13, 2014, 50 days after receiving the submission on April 24, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K141055 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2014
Decision Date June 13, 2014
Days to Decision 50 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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