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FDA 510(k)

PATHFAST HSCRP

K-Number: K083412 · 2009-03-09

ApplicantMitsubishi Kagaku Iatron
Decision Date2009-03-09
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PATHFAST HSCRP 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 2009-03-09 under 510(k) number K083412. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFAST HSCRP?

PATHFAST HSCRP is a medical device that received FDA 510(k) clearance on 2009-03-09. The listed applicant is Mitsubishi Kagaku Iatron. The 510(k) number is K083412.

When did PATHFAST HSCRP receive FDA 510(k) clearance?

PATHFAST HSCRP received FDA 510(k) clearance on 2009-03-09, under 510(k) number K083412.

Who is the listed applicant for PATHFAST HSCRP?

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 HSCRP?

The FDA product code for PATHFAST HSCRP is DCN.

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-IIK072288PATHFAST D-DIMERK072189PATHFAST NTPROBNP AND D-DIMER TESTS

Related Devices (Code: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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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