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FDA 510(k)

ULTRA LYTE POTASSIUM REAGENT KIT

K-Number: K843454 · 1984-11-27

ApplicantUltra Quest Diagnostics, Inc.
Decision Date1984-11-27
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA LYTE POTASSIUM REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ultra Quest Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K843454. 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 ULTRA LYTE POTASSIUM REAGENT KIT?

ULTRA LYTE POTASSIUM REAGENT KIT is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Ultra Quest Diagnostics, Inc.. The 510(k) number is K843454.

When did ULTRA LYTE POTASSIUM REAGENT KIT receive FDA 510(k) clearance?

ULTRA LYTE POTASSIUM REAGENT KIT received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843454.

Who is the listed applicant for ULTRA LYTE POTASSIUM REAGENT KIT?

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

What is the FDA product code for ULTRA LYTE POTASSIUM REAGENT KIT?

The FDA product code for ULTRA LYTE POTASSIUM REAGENT KIT 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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Other records listing Ultra Quest Diagnostics, 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.

K843453ULTRA LYTE SODIUM REAGENT KITK842315ULTRA LYTE ANALYZER I 100

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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