Alinity c Benzodiazepines Reagent Kit— 510(k) K243498

Name: FDA 510(k) clearance K243498
Creator: U.S. Food and Drug Administration
Published: 2024-12-11

Substantially Equivalent

Microgenics Corporation

FDA 510(k) clearance K243498 for Alinity c Benzodiazepines Reagent Kit, Substantially Equivalent on 2024-12-11. Applicant: Microgenics Corporation. Device class: 2.

Clearance details

Applicant: Microgenics Corporation
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 2024-11-12
Decision date: 2024-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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