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FDA 510(k)

PATHFAST D-DIMER

K-Number: K072288 · 2009-05-06

ApplicantMitsubishi Kagaku Iatron
Decision Date2009-05-06
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PATHFAST D-DIMER is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Kagaku Iatron. It received FDA 510(k) clearance on 2009-05-06 under 510(k) number K072288. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFAST D-DIMER?

PATHFAST D-DIMER is a medical device that received FDA 510(k) clearance on 2009-05-06. The listed applicant is Mitsubishi Kagaku Iatron. The 510(k) number is K072288.

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

PATHFAST D-DIMER received FDA 510(k) clearance on 2009-05-06, under 510(k) number K072288.

Who is the listed applicant for PATHFAST D-DIMER?

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

What is the FDA product code for PATHFAST D-DIMER?

The FDA product code for PATHFAST D-DIMER is GHH.

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.

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Other records listing Mitsubishi Kagaku Iatron 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.

K081360PATHFAST CK-MB-II, PATHFAST MYO-IIK083412PATHFAST HSCRPK072189PATHFAST NTPROBNP AND D-DIMER TESTS

Related Devices (Code: GHH)

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.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K021877MDA D-DIMERbioMerieux, 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.

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