Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NOFACT IX

K-Number: K102908 · 2011-12-19

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

Device Summary

NOFACT IX 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 K102908. 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 IX?

NOFACT IX 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 K102908.

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

NOFACT IX received FDA 510(k) clearance on 2011-12-19, under 510(k) number K102908.

Who is the listed applicant for NOFACT IX?

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 IX?

The FDA product code for NOFACT IX is GJT.

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 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.

K102851NOFACT VIIIK090105LUPOTEK KCTK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAK082631THROMBO TEK PSE, MODEL 90-480K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2K050817T-TEK

View all 10 devices →

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 COK102851NOFACT VIIIR2 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 →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑