CEDIA(R) GENTAMICIN ASSAY— 510(k) K913470

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K913470 for CEDIA(R) GENTAMICIN ASSAY, Substantially Equivalent on 1991-09-27. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1991-08-05
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, 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.