Luminex LX 100/200 Instrument
FDA 510(k) K073506 · Luminex Corp.
510(k) numberK073506
Submission
- Device name
- Luminex LX 100/200 Instrument
- Applicant
- Luminex Corp.
Toronto, CA - Received
- December 13, 2007
- Decision date
- March 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NSU – Instrumentation For Clinical Multiplex Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing…
Other 510(k)s with product code NSU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163652 | ePlex InstrumentNSU · Traditional | Genmark Diagnostics, Incorporated | 06/09/2017SE |
| K143178 | FilmArray 2.0 SystemNSU · Traditional | Biofire Diagnostics, LLC | 01/30/2015SE |
| K133849 | Vantera Clinical AnalyzerNSU · Special | Liposcience | 10/22/2014SE |
| K141220 | Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS SoftwareNSU · Special | Thermo Fisher Scientific (Life Technologies Holdin | 05/22/2014SE |
| K133302 | Flexmap 3DNSU · Traditional | Luminex Corp. | 01/10/2014SE |
| K121399 | Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD…NSU · Traditional | Luminex Corp. | 01/09/2013SE |
| K110786 | Esensor Warfarin Sensitivity Saliva TestNSU · Traditional | GenMark Diagnostics, Inc. | 12/02/2011SE |
| K093128 | Illumina Beadxpress SystemNSU · Traditional | Illumina, Inc. | 04/28/2010SE |
| K082562 | Applied Biosystems 7500 Fast DXNSU · Traditional | Applied Biosystems, Inc. | 09/30/2008SE |
| K080995 | Modification to Affymetrix Genechip Microarray Instrumentation SystemNSU · Traditional | Affymetrix, Inc. | 07/30/2008SE |
More from Affymetrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | 05/19/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | 06/06/2025SE |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | 04/18/2025SE |
| K240627 | LIAISON PLEX Yeast Blood Culture AssayPEO · Traditional | 06/04/2024SE |
| K233410 | LIAISON PLEX Respiratory Flex AssayQOF · Traditional | 03/01/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | 09/25/2019SE |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | 10/30/2017SE |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional | 07/21/2017SE |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ · Traditional | 05/02/2017SE |
| K162772 | ARIES GBS AssayNJR · Traditional | 12/23/2016SE |
Questions and answers
When was Luminex LX 100/200 Instrument cleared by the FDA?
Luminex LX 100/200 Instrument (K073506) received a 510(k) decision of Substantially Equivalent on March 7, 2008, 85 days after the submission was received.
What is the product code of K073506?
The FDA product code is NSU – Instrumentation For Clinical Multiplex Test Systems, a Class II (moderate risk) device regulated under 21 CFR 862.2570.