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FDA 510(k)

MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI

K-Number: K844559 · 1985-01-18

ApplicantThermo Orion
Decision Date1985-01-18
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Orion. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K844559. 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 MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI?

MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Thermo Orion. The 510(k) number is K844559.

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

MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI received FDA 510(k) clearance on 1985-01-18, under 510(k) number K844559.

Who is the listed applicant for MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI?

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+(SODIUM/POTASSIUM)ANALYZER MULTI?

The FDA product code for MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI 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.

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 A9100-103SK821822MODEL 1020 NA/K ANALYZER

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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