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FDA 510(k)

KODAK EKTACHEM DTII SYSTEM

K-Number: K912844 · 1991-09-04

ApplicantEastman Kodak Company
Decision Date1991-09-04
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAK EKTACHEM DTII SYSTEM 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 1991-09-04 under 510(k) number K912844. 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 DTII SYSTEM?

KODAK EKTACHEM DTII SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-04. The listed applicant is Eastman Kodak Company. The 510(k) number is K912844.

When did KODAK EKTACHEM DTII SYSTEM receive FDA 510(k) clearance?

KODAK EKTACHEM DTII SYSTEM received FDA 510(k) clearance on 1991-09-04, under 510(k) number K912844.

Who is the listed applicant for KODAK EKTACHEM DTII SYSTEM?

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 DTII SYSTEM?

The FDA product code for KODAK EKTACHEM DTII SYSTEM is JJE.

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Other records listing Eastman Kodak Company as applicant

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K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

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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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