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FDA 510(k)

AVL #980 ELECTROLYTE ANALYZER

K-Number: K801011 · 1980-07-08

ApplicantGauntlet Technology Corp.
Decision Date1980-07-08
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AVL #980 ELECTROLYTE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Gauntlet Technology Corp.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801011. 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 AVL #980 ELECTROLYTE ANALYZER?

AVL #980 ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Gauntlet Technology Corp.. The 510(k) number is K801011.

When did AVL #980 ELECTROLYTE ANALYZER receive FDA 510(k) clearance?

AVL #980 ELECTROLYTE ANALYZER received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801011.

Who is the listed applicant for AVL #980 ELECTROLYTE ANALYZER?

The FDA 510(k) record lists Gauntlet Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVL #980 ELECTROLYTE ANALYZER?

The FDA product code for AVL #980 ELECTROLYTE ANALYZER is JGS.

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 Gauntlet Technology Corp. 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.

K792230AVL MODEL 940 AUTOMATIC PH/BLOOD GAS

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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