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FDA 510(k)

KODAK EKTACHEM ELECTROLYTE ANALYZER

K-Number: K800054 · 1980-02-05

ApplicantEastman Kodak Company
Decision Date1980-02-05
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAK EKTACHEM ELECTROLYTE 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 1980-02-05 under 510(k) number K800054. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK EKTACHEM ELECTROLYTE ANALYZER?

KODAK EKTACHEM ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Eastman Kodak Company. The 510(k) number is K800054.

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

KODAK EKTACHEM ELECTROLYTE ANALYZER received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800054.

Who is the listed applicant for KODAK EKTACHEM ELECTROLYTE 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 ELECTROLYTE ANALYZER?

The FDA product code for KODAK EKTACHEM ELECTROLYTE ANALYZER is CEM.

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Other records listing Eastman Kodak Company as applicant

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Related Devices (Code: CEM)

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.

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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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