Cleared Traditional

LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL

K110239 · Lin-Zhi International, Inc. · Chemistry
Jun 2011
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K110239 is an FDA 510(k) clearance for the LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 23, 2011, 148 days after receiving the submission on January 26, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K110239 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2011
Decision Date June 23, 2011
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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