Cleared Traditional

BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS

K090844 · Lin-Zhi International, Inc. · Toxicology
Jul 2009
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K090844 is an FDA 510(k) clearance for the BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on July 30, 2009, 125 days after receiving the submission on March 27, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K090844 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2009
Decision Date July 30, 2009
Days to Decision 125 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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