CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5— 510(k) K030616

Name: FDA 510(k) clearance K030616
Creator: U.S. Food and Drug Administration
Published: 2003-03-31

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K030616 for CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5, Substantially Equivalent on 2003-03-31. 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: 2003-02-26
Decision date: 2003-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

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