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FDA 510(k)

TC MATRIX CLINICAL CHEMISTRY ANALYZER

K-Number: K073370 · 2008-05-08

ApplicantTeco Diagnostics
Decision Date2008-05-08
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TC MATRIX CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2008-05-08 under 510(k) number K073370. 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 TC MATRIX CLINICAL CHEMISTRY ANALYZER?

TC MATRIX CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2008-05-08. The listed applicant is Teco Diagnostics. The 510(k) number is K073370.

When did TC MATRIX CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

TC MATRIX CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 2008-05-08, under 510(k) number K073370.

Who is the listed applicant for TC MATRIX CLINICAL CHEMISTRY ANALYZER?

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

What is the FDA product code for TC MATRIX CLINICAL CHEMISTRY ANALYZER?

The FDA product code for TC MATRIX CLINICAL CHEMISTRY ANALYZER is JJE.

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Other records listing Teco Diagnostics as applicant

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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440K063701TECO HOMOCYSTEINE ENZYMATIC ASSAY

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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.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK063144VITROS 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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