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FDA 510(k)

ULTRA LYTE SODIUM REAGENT KIT

K-Number: K843453 · 1984-11-27

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

Device Summary

ULTRA LYTE SODIUM 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 K843453. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA LYTE SODIUM REAGENT KIT?

ULTRA LYTE SODIUM 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 K843453.

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

ULTRA LYTE SODIUM REAGENT KIT received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843453.

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

The FDA product code for ULTRA LYTE SODIUM REAGENT KIT is JGS.

Related Clinical Trials

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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.

K843454ULTRA LYTE POTASSIUM REAGENT KITK842315ULTRA LYTE ANALYZER I 100

Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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