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FDA 510(k)

SERA-210 ELECTROLYTE ANALYZER

K-Number: K853356 · 1985-09-03

ApplicantHoriba Instruments, Inc.
Decision Date1985-09-03
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERA-210 ELECTROLYTE ANALYZER 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 1985-09-03 under 510(k) number K853356. 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 SERA-210 ELECTROLYTE ANALYZER?

SERA-210 ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 1985-09-03. The listed applicant is Horiba Instruments, Inc.. The 510(k) number is K853356.

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

SERA-210 ELECTROLYTE ANALYZER received FDA 510(k) clearance on 1985-09-03, under 510(k) number K853356.

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

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 SERA-210 ELECTROLYTE ANALYZER?

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

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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-252K844806MODIFY ELECTROLYTE ANALYZER MODEL SERA-210K841424ELECTROLYTE ANALYZER SERA-210K841441SERA-250

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

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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