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 HDLC FLEX REAGENT CARTRIDGE

K-Number: K081300 · 2008-07-02

ApplicantSiemens Healthcare Diagnostics
Decision Date2008-07-02
Product CodeJHM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA HDLC 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 2008-07-02 under 510(k) number K081300. The device is classified under product code JHM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE?

DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 2008-07-02. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K081300.

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

DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 2008-07-02, under 510(k) number K081300.

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

The FDA product code for DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE is JHM.

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: JHM)

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.

K120662PICCOLO HDL-CAPILLARY TEST SYSTEMAbaxis, Inc.K073072DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48BDade Behring, Inc.K032798DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48ADade Behring, Inc.K022519LDL CHOLESTEROL (AUTOMATED)Jas Diagnostics, Inc.K983849DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGEDade Behring, Inc.K902935ROCHE COBAS READY HDL CHOLESTEROL REAGENTRoche Diagnostic Systems, 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.

↑