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)

ABBOTT VISION LYTE (TM) SODIUM

K-Number: K903188 · 1990-09-10

ApplicantAbbott Laboratories
Decision Date1990-09-10
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT VISION LYTE (TM) SODIUM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K903188. 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 ABBOTT VISION LYTE (TM) SODIUM?

ABBOTT VISION LYTE (TM) SODIUM is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Abbott Laboratories. The 510(k) number is K903188.

When did ABBOTT VISION LYTE (TM) SODIUM receive FDA 510(k) clearance?

ABBOTT VISION LYTE (TM) SODIUM received FDA 510(k) clearance on 1990-09-10, under 510(k) number K903188.

Who is the listed applicant for ABBOTT VISION LYTE (TM) SODIUM?

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

What is the FDA product code for ABBOTT VISION LYTE (TM) SODIUM?

The FDA product code for ABBOTT VISION LYTE (TM) SODIUM 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 Abbott Laboratories 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.

K262156Anti-HCV NextK252424Anti-HCV NextK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgGK243283Alinity h-series SystemK233932Alinity i Toxo IgM

View all 876 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.

↑