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FDA 510(k)

MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER

K-Number: K003721 · 2000-12-18

ApplicantOlympus America, Inc.
Decision Date2000-12-18
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2000-12-18 under 510(k) number K003721. 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 MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER?

MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2000-12-18. The listed applicant is Olympus America, Inc.. The 510(k) number is K003721.

When did MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 2000-12-18, under 510(k) number K003721.

Who is the listed applicant for MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER?

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

What is the FDA product code for MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER?

The FDA product code for MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER is JJE.

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Other records listing Olympus America, Inc. as applicant

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K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073490OLYMPUS IGG REAGENTK073487OLYMPUS IGM REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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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