DRI COTININE EIA ASSAY— 510(k) K030649

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K030649 for DRI COTININE EIA ASSAY, Substantially Equivalent on 2003-05-22. Applicant: Microgenics Corp.. Device class: 1.

Clearance details

Applicant: Microgenics Corp.
Product code: Code MRS
Device class: Class 1
Regulation: 21 CFR 862.3220
Advisory panel: Clinical Toxicology
Date received: 2003-02-28
Decision date: 2003-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

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