Cleared Traditional

OPIATE ENZYME IMMUNOASSAY

K110298 · Lin-Zhi International, Inc. · Chemistry
Jul 2011
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K110298 is an FDA 510(k) clearance for the OPIATE ENZYME IMMUNOASSAY, 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 July 15, 2011, 164 days after receiving the submission on February 1, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K110298 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2011
Decision Date July 15, 2011
Days to Decision 164 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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