Cleared Special

Alinity c Benzodiazepines Reagent Kit

K243498 · Microgenics Corporation · Toxicology
Dec 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K243498 is an FDA 510(k) clearance for the Alinity c Benzodiazepines Reagent Kit, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on December 11, 2024, 29 days after receiving the submission on November 12, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K243498 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date December 11, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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