CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS— 510(k) K935904

Name: FDA 510(k) clearance K935904
Creator: U.S. Food and Drug Administration
Published: 1994-03-11

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K935904 for CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS, Substantially Equivalent on 1994-03-11. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1993-12-10
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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