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FDA 510(k)

TECHLYTE ELECTROLYTE ANALYZER

K-Number: K905600 · 1991-01-15

ApplicantTechnalysis, Inc.
Decision Date1991-01-15
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHLYTE ELECTROLYTE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Technalysis, Inc.. It received FDA 510(k) clearance on 1991-01-15 under 510(k) number K905600. 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 TECHLYTE ELECTROLYTE ANALYZER?

TECHLYTE ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is Technalysis, Inc.. The 510(k) number is K905600.

When did TECHLYTE ELECTROLYTE ANALYZER receive FDA 510(k) clearance?

TECHLYTE ELECTROLYTE ANALYZER received FDA 510(k) clearance on 1991-01-15, under 510(k) number K905600.

Who is the listed applicant for TECHLYTE ELECTROLYTE ANALYZER?

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

What is the FDA product code for TECHLYTE ELECTROLYTE ANALYZER?

The FDA product code for TECHLYTE 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 Technalysis, 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.

K923773CELLEXIS HEMATOLOGY ANALYZERK885091HEMAVIEW DARKFIELD MICROSCOPE SYSTEM

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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