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FDA 510(k)

SODIUM/POTASSIUM REAGENT KITS

K-Number: K811310 · 1981-07-10

ApplicantChem-Elec, Inc.
Decision Date1981-07-10
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM/POTASSIUM REAGENT KITS is the device name listed in this FDA 510(k) record. The listed applicant is Chem-Elec, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811310. 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 SODIUM/POTASSIUM REAGENT KITS?

SODIUM/POTASSIUM REAGENT KITS is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Chem-Elec, Inc.. The 510(k) number is K811310.

When did SODIUM/POTASSIUM REAGENT KITS receive FDA 510(k) clearance?

SODIUM/POTASSIUM REAGENT KITS received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811310.

Who is the listed applicant for SODIUM/POTASSIUM REAGENT KITS?

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

What is the FDA product code for SODIUM/POTASSIUM REAGENT KITS?

The FDA product code for SODIUM/POTASSIUM REAGENT KITS is CEM.

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Other records listing Chem-Elec, Inc. as applicant

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.

K943503CHEMCARD GLUCOSE TESTK864159SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODK811381ASTRAK811406CREATININE RATE REAGENT KITK811165GLUCOSE OXIDASE RATE REAGENTK811319CHLORIDE REAGENT KIT

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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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