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FDA 510(k)

SKD ELECTROCHEMICAL SYSTEM (ECS)

K-Number: K854723 · 1986-03-05

ApplicantSmithkline Diagnostics, Inc.
Decision Date1986-03-05
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SKD ELECTROCHEMICAL SYSTEM (ECS) is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-03-05 under 510(k) number K854723. 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 SKD ELECTROCHEMICAL SYSTEM (ECS)?

SKD ELECTROCHEMICAL SYSTEM (ECS) is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K854723.

When did SKD ELECTROCHEMICAL SYSTEM (ECS) receive FDA 510(k) clearance?

SKD ELECTROCHEMICAL SYSTEM (ECS) received FDA 510(k) clearance on 1986-03-05, under 510(k) number K854723.

Who is the listed applicant for SKD ELECTROCHEMICAL SYSTEM (ECS)?

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

What is the FDA product code for SKD ELECTROCHEMICAL SYSTEM (ECS)?

The FDA product code for SKD ELECTROCHEMICAL SYSTEM (ECS) is CEM.

Related Clinical Trials

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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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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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