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)

GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+

K-Number: K082462 · 2009-02-06

ApplicantDiamond Diagnostics, Inc.
Decision Date2009-02-06
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K082462. 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 GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+?

GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K082462.

When did GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ receive FDA 510(k) clearance?

GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ received FDA 510(k) clearance on 2009-02-06, under 510(k) number K082462.

Who is the listed applicant for GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+?

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

What is the FDA product code for GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+?

The FDA product code for GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ 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 Diamond Diagnostics, 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.

K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION CK121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHK121040SMARTLYTE ELECTROLYTE ANALYZERK121140PROLYTE ELECTROLYTE ANALYZERK120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2

View all 25 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.

↑