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FDA 510(k)

KODAK EKTACCHEM 950IRC ANALYZER

K-Number: K946090 · 1995-01-17

ApplicantClinical Diagnostic Systems, Inc.
Decision Date1995-01-17
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAK EKTACCHEM 950IRC ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K946090. 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 EKTACCHEM 950IRC ANALYZER?

KODAK EKTACCHEM 950IRC ANALYZER is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Clinical Diagnostic Systems, Inc.. The 510(k) number is K946090.

When did KODAK EKTACCHEM 950IRC ANALYZER receive FDA 510(k) clearance?

KODAK EKTACCHEM 950IRC ANALYZER received FDA 510(k) clearance on 1995-01-17, under 510(k) number K946090.

Who is the listed applicant for KODAK EKTACCHEM 950IRC ANALYZER?

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

What is the FDA product code for KODAK EKTACCHEM 950IRC ANALYZER?

The FDA product code for KODAK EKTACCHEM 950IRC ANALYZER is JJE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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