IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP— 510(k) K063057

Name: FDA 510(k) clearance K063057
Creator: U.S. Food and Drug Administration
Published: 2006-12-22

Substantially Equivalent

Diagnostic Products Corporation

FDA 510(k) clearance K063057 for IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP, Substantially Equivalent on 2006-12-22. Applicant: Diagnostic Products Corporation. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corporation
Product code: Code NQD
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2006-10-05
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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