CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)— 510(k) K030590

Name: FDA 510(k) clearance K030590
Creator: U.S. Food and Drug Administration
Published: 2003-03-21

Substantially Equivalent

Hitachi Chemical Diagnostics, Inc.

FDA 510(k) clearance K030590 for CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82), Substantially Equivalent on 2003-03-21. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 2003-02-25
Decision date: 2003-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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