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FDA 510(k)

ELECTROLYTE ANALYZER SERA-210

K-Number: K841424 · 1984-06-22

ApplicantHoriba Instruments, Inc.
Decision Date1984-06-22
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECTROLYTE ANALYZER SERA-210 is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Instruments, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K841424. 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 ELECTROLYTE ANALYZER SERA-210?

ELECTROLYTE ANALYZER SERA-210 is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Horiba Instruments, Inc.. The 510(k) number is K841424.

When did ELECTROLYTE ANALYZER SERA-210 receive FDA 510(k) clearance?

ELECTROLYTE ANALYZER SERA-210 received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841424.

Who is the listed applicant for ELECTROLYTE ANALYZER SERA-210?

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

What is the FDA product code for ELECTROLYTE ANALYZER SERA-210?

The FDA product code for ELECTROLYTE ANALYZER SERA-210 is JGS.

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Other records listing Horiba Instruments, 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.

K853405ELECTROLYTE ANALYZER SERA-252K853356SERA-210 ELECTROLYTE ANALYZERK844806MODIFY ELECTROLYTE ANALYZER MODEL SERA-210K841441SERA-250

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

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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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