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)

HICHEM ISE ELECTROLYTE BUFFER

K-Number: K992844 · 1999-11-26

ApplicantElan Holdings, Inc.
Decision Date1999-11-26
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ISE ELECTROLYTE BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Elan Holdings, Inc.. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K992844. 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 HICHEM ISE ELECTROLYTE BUFFER?

HICHEM ISE ELECTROLYTE BUFFER is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K992844.

When did HICHEM ISE ELECTROLYTE BUFFER receive FDA 510(k) clearance?

HICHEM ISE ELECTROLYTE BUFFER received FDA 510(k) clearance on 1999-11-26, under 510(k) number K992844.

Who is the listed applicant for HICHEM ISE ELECTROLYTE BUFFER?

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

What is the FDA product code for HICHEM ISE ELECTROLYTE BUFFER?

The FDA product code for HICHEM ISE ELECTROLYTE BUFFER 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 Elan Holdings, 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.

K013152ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITSK012474ATAC PAK CPK REAGENT KITK010488ATAC PAK AST REAGENT KITK000958ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITSK000900ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITSK992842HICHEM ISE ELECTROLYTE REFERENCE

View all 12 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.

↑