FDA 510(k)

HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE

K-Number: K111753 · 2011-12-14

ApplicantHitachi Chemical Diagnostics, Inc.

Decision Date2011-12-14

Product CodeCHH

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-12-14 under 510(k) number K111753. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE?

HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE is a medical device that received FDA 510(k) clearance on 2011-12-14. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K111753.

When did HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE receive FDA 510(k) clearance?

HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE received FDA 510(k) clearance on 2011-12-14, under 510(k) number K111753.

Who is the listed applicant for HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE?

The FDA 510(k) record lists Hitachi Chemical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE?

The FDA product code for HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE is CHH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.