DCL MICROALBUMIN ASSAY, MODEL 252-20— 510(k) K051191

Name: FDA 510(k) clearance K051191
Creator: U.S. Food and Drug Administration
Published: 2005-07-05

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K051191 for DCL MICROALBUMIN ASSAY, MODEL 252-20, Substantially Equivalent on 2005-07-05. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 2005-05-10
Decision date: 2005-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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