Panels › Clinical Chemistry › Product code NSU · Class 2
Instrumentation For Clinical Multiplex Test Systems
Regulation 862.2570
0510(k)s in 12 months (13 all time)
2recalls in 12 months (14 all time)
6recalls that name a 510(k)
Top companies in NSU
| Company | 510(k)s | Recalls |
|---|---|---|
| Hologic, Inc | 0 | 4 |
| Luminex Corp. | 3 | 1 |
| Affymetrix, Inc. | 2 | 1 |
| Becton Dickinson & Co. | 0 | 3 |
| Biofire Diagnostics, LLC | 1 | 2 |
| GenMark Diagnostics, Inc. | 2 | 0 |
| Nuclein LLC | 0 | 2 |
| Applied Biosystems, Inc. | 1 | 0 |
| Illumina, Inc. | 1 | 0 |
| Liposcience | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2017 | K163652 | ePlex Instrument Genmark Diagnostics, Incorporated | NSU |
| Jan 30, 2015 | K143178 | FilmArray 2.0 System Biofire Diagnostics, LLC | NSU |
| Oct 22, 2014 | K133849 | VANTERA CLINICAL ANALYZER Liposcience | NSU |
| May 22, 2014 | K141220 | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE Thermo Fisher Scientific (Life Technologies Holdin, SG | NSU |
| Jan 10, 2014 | K133302 | FLEXMAP 3D Luminex Corp. | NSU |
| Jan 9, 2013 | K121399 | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P Luminex Corp. | NSU |
| Dec 2, 2011 | K110786 | ESENSOR WARFARIN SENSITIVITY SALIVA TEST GenMark Diagnostics, Inc. | NSU |
| Apr 28, 2010 | K093128 | ILLUMINA BEADXPRESS SYSTEM Illumina, Inc. | NSU |
| Sep 30, 2008 | K082562 | APPLIED BIOSYSTEMS 7500 FAST DX Applied Biosystems, Inc. | NSU |
| Jul 30, 2008 | K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. | NSU |
| Mar 7, 2008 | K073506 | LUMINEX LX 100/200 INSTRUMENT Luminex Corp., CA | NSU |
| Oct 11, 2007 | K070597 | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST Nanosphere, Inc. | NSU |
| Dec 23, 2004 | DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. | NSU |
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