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FDA 510(k)

HEMOSIL D-DIMER HS

K-Number: K050544 · 2005-04-26

ApplicantInstrumentation Laboratory CO
Decision Date2005-04-26
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL D-DIMER HS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2005-04-26 under 510(k) number K050544. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSIL D-DIMER HS?

HEMOSIL D-DIMER HS is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K050544.

When did HEMOSIL D-DIMER HS receive FDA 510(k) clearance?

HEMOSIL D-DIMER HS received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050544.

Who is the listed applicant for HEMOSIL D-DIMER HS?

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

What is the FDA product code for HEMOSIL D-DIMER HS?

The FDA product code for HEMOSIL D-DIMER HS is DAP.

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 Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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Related Devices (Code: DAP)

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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory COK112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare Diagnostics

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.

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