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FDA 510(k)

STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER

K-Number: K042169 · 2005-03-14

ApplicantStanbio Laboratory
Decision Date2005-03-14
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 2005-03-14 under 510(k) number K042169. 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 STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER?

STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2005-03-14. The listed applicant is Stanbio Laboratory. The 510(k) number is K042169.

When did STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 2005-03-14, under 510(k) number K042169.

Who is the listed applicant for STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER?

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

What is the FDA product code for STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER?

The FDA product code for STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER is JJE.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAYK032936DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR

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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 OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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