DRI OXYCODONE ASSAY— 510(k) K040411

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K040411 for DRI OXYCODONE ASSAY, Substantially Equivalent on 2004-05-27. Applicant: Microgenics Corp.. Device class: 1.

Clearance details

Applicant: Microgenics Corp.
Product code: Code LAS
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 2004-02-18
Decision date: 2004-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.