HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE— 510(k) K111753

Name: FDA 510(k) clearance K111753
Creator: U.S. Food and Drug Administration
Published: 2011-12-14

Substantially Equivalent

Hitachi Chemical Diagnostics, Inc.

FDA 510(k) clearance K111753 for HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE, Substantially Equivalent on 2011-12-14. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2011-06-22
Decision date: 2011-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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