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)

POTASSIUM ANALYZER-SODIUM/ELECTROLYTE

K-Number: K830588 · 1983-04-27

ApplicantShaban Mfg. Co.
Decision Date1983-04-27
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POTASSIUM ANALYZER-SODIUM/ELECTROLYTE is the device name listed in this FDA 510(k) record. The listed applicant is Shaban Mfg. Co.. It received FDA 510(k) clearance on 1983-04-27 under 510(k) number K830588. 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 POTASSIUM ANALYZER-SODIUM/ELECTROLYTE?

POTASSIUM ANALYZER-SODIUM/ELECTROLYTE is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Shaban Mfg. Co.. The 510(k) number is K830588.

When did POTASSIUM ANALYZER-SODIUM/ELECTROLYTE receive FDA 510(k) clearance?

POTASSIUM ANALYZER-SODIUM/ELECTROLYTE received FDA 510(k) clearance on 1983-04-27, under 510(k) number K830588.

Who is the listed applicant for POTASSIUM ANALYZER-SODIUM/ELECTROLYTE?

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

What is the FDA product code for POTASSIUM ANALYZER-SODIUM/ELECTROLYTE?

The FDA product code for POTASSIUM ANALYZER-SODIUM/ELECTROLYTE 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 Shaban Mfg. Co. 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.

K853621REPLACEMENT PUMP TUBINGK850157CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERSK850333PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERSK844781MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LABK844235CHLORIDE STANDARDK842656REPLACEMENT PARTS NOVA ELECTROLYTE ANAL

View all 35 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑