The following data is part of a premarket notification filed by Luminex Corp. with the FDA for Luminex Flexmap 3d Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3d Ivd Calibration Kit, Flexmap 3d Ivd P.
| Device ID | K121399 |
| 510k Number | K121399 |
| Device Name: | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | LUMINEX CORP. 12212 Technology Blvd Austin, TX 78727 |
| Contact | Oliver Meek |
| Correspondent | Oliver Meek LUMINEX CORP. 12212 Technology Blvd Austin, TX 78727 |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-09 |
| Decision Date | 2013-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487100363 | K121399 | 000 |
| 00840487100356 | K121399 | 000 |
| 00840487100301 | K121399 | 000 |