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FDA 510(k)

COULTER ELECTROLYTE ANALYZER SYSTEM

K-Number: K781528 · 1978-09-27

ApplicantCoulter Electronics, Inc.
Decision Date1978-09-27
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER ELECTROLYTE ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781528. 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 COULTER ELECTROLYTE ANALYZER SYSTEM?

COULTER ELECTROLYTE ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K781528.

When did COULTER ELECTROLYTE ANALYZER SYSTEM receive FDA 510(k) clearance?

COULTER ELECTROLYTE ANALYZER SYSTEM received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781528.

Who is the listed applicant for COULTER ELECTROLYTE ANALYZER SYSTEM?

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

What is the FDA product code for COULTER ELECTROLYTE ANALYZER SYSTEM?

The FDA product code for COULTER ELECTROLYTE ANALYZER SYSTEM is JJE.

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Other records listing Coulter Electronics, Inc. as applicant

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K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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