FDA Product Code
FDA Product Code NSU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2570
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163652 | ePlex Instrument | Genmark Diagnostics, Incorporated | 2017-06-09 | Traditional | PDF ↗ |
| K143178 | FilmArray 2.0 System | Biofire Diagnostics, LLC | 2015-01-30 | Traditional | PDF ↗ |
| K133849 | VANTERA CLINICAL ANALYZER | Liposcience | 2014-10-22 | Special | PDF ↗ |
| K141220 | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE | Thermo Fisher Scientific (Life Technologies Holdin | 2014-05-22 | Special | PDF ↗ |
| K133302 | FLEXMAP 3D | Luminex Corp. | 2014-01-10 | Traditional | PDF ↗ |
| K121399 | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P | Luminex Corp. | 2013-01-09 | Traditional | PDF ↗ |
| K110786 | ESENSOR WARFARIN SENSITIVITY SALIVA TEST | GenMark Diagnostics, Inc. | 2011-12-02 | Traditional | PDF ↗ |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | Illumina, Inc. | 2010-04-28 | Traditional | PDF ↗ |
| K082562 | APPLIED BIOSYSTEMS 7500 FAST DX | Applied Biosystems, Inc. | 2008-09-30 | Traditional | PDF ↗ |
| K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | 2008-07-30 | Traditional | PDF ↗ |
| K073506 | LUMINEX LX 100/200 INSTRUMENT | Luminex Corp. | 2008-03-07 | Traditional | PDF ↗ |
| K070597 | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST | Nanosphere, Inc. | 2007-10-11 | Traditional | PDF ↗ |
| DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | 2004-12-23 | Post-NSE | — |
Product code NSU · Class II · Clinical Chemistry. Data: openFDA.