CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION— 510(k) K905521

Name: FDA 510(k) clearance K905521
Creator: U.S. Food and Drug Administration
Published: 1990-12-26

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K905521 for CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION, Substantially Equivalent on 1990-12-26. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code LER
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1990-12-07
Decision date: 1990-12-26
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.