Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ELECTROLYTE ANALYZER

K-Number: K851808 · 1985-06-25

ApplicantIonetics, Inc.
Decision Date1985-06-25
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECTROLYTE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Ionetics, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K851808. 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 ELECTROLYTE ANALYZER?

ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Ionetics, Inc.. The 510(k) number is K851808.

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

ELECTROLYTE ANALYZER received FDA 510(k) clearance on 1985-06-25, under 510(k) number K851808.

Who is the listed applicant for ELECTROLYTE ANALYZER?

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

What is the FDA product code for ELECTROLYTE ANALYZER?

The FDA product code for ELECTROLYTE ANALYZER is CEM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ionetics, 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.

K932179MODEL 400/450 ELECTROLYTE ANALYZERK895397CALCIUM AND PH ELECTROLYTE ANALYZERK890792POTASSIUM AND SODIUM ELECTROLYTE ANALYZERK863907MODIFIED SODIUM ELECTRODEK830130MINIATURE ION SELECTIVE ELECTRODESK802856MINIATURE ION SELECTIVE ELECTRODES

View all 7 devices →

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.

↑