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FDA 510(k)

DIMENSION CLINICAL CHEMISTRY SYSTEM

K-Number: K112999 · 2011-11-22

ApplicantSiemens Healthcare Diagnostics
Decision Date2011-11-22
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION CLINICAL CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2011-11-22 under 510(k) number K112999. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION CLINICAL CHEMISTRY SYSTEM?

DIMENSION CLINICAL CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K112999.

When did DIMENSION CLINICAL CHEMISTRY SYSTEM receive FDA 510(k) clearance?

DIMENSION CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance on 2011-11-22, under 510(k) number K112999.

Who is the listed applicant for DIMENSION CLINICAL CHEMISTRY SYSTEM?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION CLINICAL CHEMISTRY SYSTEM?

The FDA product code for DIMENSION CLINICAL CHEMISTRY SYSTEM is JJE.

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Related Devices (Code: JJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco DiagnosticsK063144VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMOrtho-Clinical Diagnostics, Inc.

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.

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