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FDA 510(k)

NOFACT VIII

K-Number: K102851 · 2011-12-19

ApplicantR2 Diagnostics, Inc.
Decision Date2011-12-19
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NOFACT VIII 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 2011-12-19 under 510(k) number K102851. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOFACT VIII?

NOFACT VIII is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is R2 Diagnostics, Inc.. The 510(k) number is K102851.

When did NOFACT VIII receive FDA 510(k) clearance?

NOFACT VIII received FDA 510(k) clearance on 2011-12-19, under 510(k) number K102851.

Who is the listed applicant for NOFACT VIII?

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 NOFACT VIII?

The FDA product code for NOFACT VIII is GJT.

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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 IXK090105LUPOTEK KCTK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAK082631THROMBO TEK PSE, MODEL 90-480K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2K050817T-TEK

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Related Devices (Code: GJT)

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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory COK102908NOFACT IXR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory COK043459HEMOSIL FACTOR XII DEFICIENT PLASMAInstrumentation Laboratory CO

Official Source

View on FDA Database →

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