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FDA 510(k)

LUMINEX LX 100/200 INSTRUMENT

K-Number: K073506 · 2008-03-07

ApplicantLuminex Corp.
Decision Date2008-03-07
Product CodeNSU
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUMINEX LX 100/200 INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corp.. It received FDA 510(k) clearance on 2008-03-07 under 510(k) number K073506. The device is classified under product code NSU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMINEX LX 100/200 INSTRUMENT?

LUMINEX LX 100/200 INSTRUMENT is a medical device that received FDA 510(k) clearance on 2008-03-07. The listed applicant is Luminex Corp.. The 510(k) number is K073506.

When did LUMINEX LX 100/200 INSTRUMENT receive FDA 510(k) clearance?

LUMINEX LX 100/200 INSTRUMENT received FDA 510(k) clearance on 2008-03-07, under 510(k) number K073506.

Who is the listed applicant for LUMINEX LX 100/200 INSTRUMENT?

The FDA 510(k) record lists Luminex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMINEX LX 100/200 INSTRUMENT?

The FDA product code for LUMINEX LX 100/200 INSTRUMENT is NSU.

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 Luminex Corp. 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.

K121399LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P

Related Devices (Code: NSU)

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.

K163652ePlex InstrumentGenmark Diagnostics, IncorporatedK121399LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD PLuminex Corp.K110786ESENSOR WARFARIN SENSITIVITY SALIVA TESTGenMark Diagnostics, Inc.K093128ILLUMINA BEADXPRESS SYSTEMIllumina, Inc.K082562APPLIED BIOSYSTEMS 7500 FAST DXApplied Biosystems, Inc.K080995MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMAffymetrix, 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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