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FDA 510(k)

MODEL 1020 NA/K ANALYZER

K-Number: K821822 · 1982-07-02

ApplicantThermo Orion
Decision Date1982-07-02
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 1020 NA/K ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Orion. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821822. 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 MODEL 1020 NA/K ANALYZER?

MODEL 1020 NA/K ANALYZER is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Thermo Orion. The 510(k) number is K821822.

When did MODEL 1020 NA/K ANALYZER receive FDA 510(k) clearance?

MODEL 1020 NA/K ANALYZER received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821822.

Who is the listed applicant for MODEL 1020 NA/K ANALYZER?

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

What is the FDA product code for MODEL 1020 NA/K ANALYZER?

The FDA product code for MODEL 1020 NA/K 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 Thermo Orion 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.

K023792CALIBRATION PACK, MODELS A9100-101S AND A9100-103SK844559MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI

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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