Cleared Traditional

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators

K170416 · Lin-Zhi International, Inc. · Toxicology
Jun 2017
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K170416 is an FDA 510(k) clearance for the LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 26, 2017, 136 days after receiving the submission on February 10, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K170416 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2017
Decision Date June 26, 2017
Days to Decision 136 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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