MODIFIED CEDIA(TM) CORTISOL ASSAY— 510(k) K896451

Name: FDA 510(k) clearance K896451
Creator: U.S. Food and Drug Administration
Published: 1989-12-12

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K896451 for MODIFIED CEDIA(TM) CORTISOL ASSAY, Substantially Equivalent on 1989-12-12. 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: 1989-11-09
Decision date: 1989-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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