FDA 510(k)

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

K-Number: K100060 · 2010-12-15

ApplicantVital Diagnostics (Manufacturing) Ptyltd

Decision Date2010-12-15

Product CodeKHS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 is the device name listed in this FDA 510(k) record. The listed applicant is Vital Diagnostics (Manufacturing) Ptyltd. It received FDA 510(k) clearance on 2010-12-15 under 510(k) number K100060. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475?

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 is a medical device that received FDA 510(k) clearance on 2010-12-15. The listed applicant is Vital Diagnostics (Manufacturing) Ptyltd. The 510(k) number is K100060.

When did EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 receive FDA 510(k) clearance?

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 received FDA 510(k) clearance on 2010-12-15, under 510(k) number K100060.

Who is the listed applicant for EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475?

The FDA 510(k) record lists Vital Diagnostics (Manufacturing) Ptyltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475?

The FDA product code for EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 is KHS.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vital Diagnostics (Manufacturing) Ptyltd as applicant

K120626EON CALCIUM REGENT K112416CPK REAGENT K111063VITAL SERUM CONTROLS K110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

Related Devices (Code: KHS)

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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.