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FDA 510(k)

FIBROTEK FIB

K-Number: K042919 · 2004-11-29

ApplicantR2 Diagnostics, Inc.
Decision Date2004-11-29
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBROTEK FIB is the device name listed in this FDA 510(k) record. The listed applicant is R2 Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-11-29 under 510(k) number K042919. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBROTEK FIB?

FIBROTEK FIB is a medical device that received FDA 510(k) clearance on 2004-11-29. The listed applicant is R2 Diagnostics, Inc.. The 510(k) number is K042919.

When did FIBROTEK FIB receive FDA 510(k) clearance?

FIBROTEK FIB received FDA 510(k) clearance on 2004-11-29, under 510(k) number K042919.

Who is the listed applicant for FIBROTEK FIB?

The FDA 510(k) record lists R2 Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIBROTEK FIB?

The FDA product code for FIBROTEK FIB is GIS.

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Other records listing R2 Diagnostics, Inc. 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.

K102908NOFACT IXK102851NOFACT VIIIK090105LUPOTEK KCTK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAK082631THROMBO TEK PSE, MODEL 90-480K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2

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Related Devices (Code: GIS)

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.

K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme LaboratoriesK993482K-ASSAY FIBRINOGENKamiya Biomedical Co.K963902QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic SpecialtiesK925494BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, Inc.K923921IL TEST PT FIBRINOGEN HSInstrumentation Laboratory CO

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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