FLEXMAP 3D
Instrumentation For Clinical Multiplex Test Systems
LUMINEX CORP.
The following data is part of a premarket notification filed by Luminex Corp. with the FDA for Flexmap 3d.
Pre-market Notification Details
| Device ID | K133302 |
| 510k Number | K133302 |
| Device Name: | FLEXMAP 3D |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | LUMINEX CORP. 12212 TECHNOLOGY BLVD. Austin, TX 78727 -6115 |
| Contact | Christie Hughes |
| Correspondent | Christie Hughes LUMINEX CORP. 12212 TECHNOLOGY BLVD. Austin, TX 78727 -6115 |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-01-10 |
Trademark Results [FLEXMAP 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXMAP 3D 77237943 3686642 Live/Registered |
Luminex Corporation 2007-07-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.