CEDIA (TM) CORTISOL ASSAY— 510(k) K901296

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K901296 for CEDIA (TM) CORTISOL ASSAY, Substantially Equivalent on 1990-04-03. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1990-03-20
Decision date: 1990-04-03
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.