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)

EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER

K-Number: K895936 · 1989-12-12

ApplicantMedica Corp.
Decision Date1989-12-12
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 1989-12-12 under 510(k) number K895936. 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 EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER?

EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Medica Corp.. The 510(k) number is K895936.

When did EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER receive FDA 510(k) clearance?

EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER received FDA 510(k) clearance on 1989-12-12, under 510(k) number K895936.

Who is the listed applicant for EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER?

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

What is the FDA product code for EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER?

The FDA product code for EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER 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 Medica Corp. 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.

K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALK111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALK112788EASTLYTE NA/K/CA/PHK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

View all 47 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.

↑