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FDA 510(k)

HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE

K-Number: K885288 · 1989-02-07

ApplicantEastman Kodak Company
Decision Date1989-02-07
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE 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 1989-02-07 under 510(k) number K885288. 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 HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE?

HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Eastman Kodak Company. The 510(k) number is K885288.

When did HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE receive FDA 510(k) clearance?

HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE received FDA 510(k) clearance on 1989-02-07, under 510(k) number K885288.

Who is the listed applicant for HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE?

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 HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE?

The FDA product code for HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE is JJE.

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Other records listing Eastman Kodak Company as applicant

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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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