CEDIA TACROLIMUS ASSAY— 510(k) K050206

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K050206 for CEDIA TACROLIMUS ASSAY, Substantially Equivalent on 2005-03-15. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code MLM
Device class: Class 2
Regulation: 21 CFR 862.1678
Advisory panel: Clinical Chemistry
Date received: 2005-01-28
Decision date: 2005-03-15
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.