The following data is part of a premarket notification filed by Luminex Corp. with the FDA for Luminex Lx 100/200 Instrument.
| Device ID | K073506 |
| 510k Number | K073506 |
| Device Name: | LUMINEX LX 100/200 INSTRUMENT |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | LUMINEX CORP. 439 UNIVERSITY AVENUE SUITE 2000 Toronto, CA M5g 1y8 |
| Contact | Nancy Krunic |
| Correspondent | Nancy Krunic LUMINEX CORP. 439 UNIVERSITY AVENUE SUITE 2000 Toronto, CA M5g 1y8 |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-13 |
| Decision Date | 2008-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234401124 | K073506 | 000 |
| 00840487100349 | K073506 | 000 |
| 00840487100332 | K073506 | 000 |
| 00840487100110 | K073506 | 000 |
| 00840487100103 | K073506 | 000 |
| 00840487100097 | K073506 | 000 |
| 00840487101780 | K073506 | 000 |
| 00840487101803 | K073506 | 000 |