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)

DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

K-Number: K112142 · 2011-11-04

ApplicantSiemens Healthcare Diagnostics
Decision Date2011-11-04
Product CodeNDW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2011-11-04 under 510(k) number K112142. The device is classified under product code NDW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE?

DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K112142.

When did DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 2011-11-04, under 510(k) number K112142.

Who is the listed applicant for DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE?

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

What is the FDA product code for DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE?

The FDA product code for DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE is NDW.

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 Siemens Healthcare Diagnostics 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.

K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)K162977ADVIA 2120i, ADVIA 2120K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALK161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorK151964Xprecia Stride Coagulation System, Xprecia System PT Controls

View all 85 devices →

Related Devices (Code: NDW)

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.

K243462Diazyme Colorimetric Lithium AssayDiazyme Laboratories, Inc.K063684COBAS LITHIUMRoche Diagnostics Corp.K063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLThermo Electron OYK070987SENTINEL LITHIUM ASSAYSENTINEL CH. SpAK050374ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLCK003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901Trace America, Inc.

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.

↑