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FDA 510(k)

KODAK EKTACHEM 500 ANALYZER

K-Number: K890928 · 1989-03-28

ApplicantEastman Kodak Company
Decision Date1989-03-28
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAK EKTACHEM 500 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K890928. 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 KODAK EKTACHEM 500 ANALYZER?

KODAK EKTACHEM 500 ANALYZER is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Eastman Kodak Company. The 510(k) number is K890928.

When did KODAK EKTACHEM 500 ANALYZER receive FDA 510(k) clearance?

KODAK EKTACHEM 500 ANALYZER received FDA 510(k) clearance on 1989-03-28, under 510(k) number K890928.

Who is the listed applicant for KODAK EKTACHEM 500 ANALYZER?

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

What is the FDA product code for KODAK EKTACHEM 500 ANALYZER?

The FDA product code for KODAK EKTACHEM 500 ANALYZER is JJE.

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Related Devices (Code: JJE)

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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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