CEDIA DIGITOXIN ASSAY— 510(k) K896021

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K896021 for CEDIA DIGITOXIN ASSAY, Substantially Equivalent on 1989-11-08. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code LFM
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1989-10-16
Decision date: 1989-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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