HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)— 510(k) K113809

Name: FDA 510(k) clearance K113809
Creator: U.S. Food and Drug Administration
Published: 2012-08-17

Substantially Equivalent

Hitachi Chemical Diagnostics, Inc.

FDA 510(k) clearance K113809 for HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP), Substantially Equivalent on 2012-08-17. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2011-12-23
Decision date: 2012-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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