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FDA 510(k)

IMDX SYSTEMS

K-Number: K063699 · 2007-06-01

ApplicantNovx Systems, Inc.
Decision Date2007-06-01
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMDX SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Novx Systems, Inc.. It received FDA 510(k) clearance on 2007-06-01 under 510(k) number K063699. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMDX SYSTEMS?

IMDX SYSTEMS is a medical device that received FDA 510(k) clearance on 2007-06-01. The listed applicant is Novx Systems, Inc.. The 510(k) number is K063699.

When did IMDX SYSTEMS receive FDA 510(k) clearance?

IMDX SYSTEMS received FDA 510(k) clearance on 2007-06-01, under 510(k) number K063699.

Who is the listed applicant for IMDX SYSTEMS?

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

What is the FDA product code for IMDX SYSTEMS?

The FDA product code for IMDX SYSTEMS is DJG.

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 Novx Systems, 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.

K080057IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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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