Cleared Traditional

LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS

K113139 · Lin-Zhi International, Inc. · Chemistry
Nov 2011
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K113139 is an FDA 510(k) clearance for the LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 22, 2011, 29 days after receiving the submission on October 24, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K113139 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2011
Decision Date November 22, 2011
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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