The following data is part of a premarket notification filed by Horiba Ltd. with the FDA for Paros Crp.
| Device ID | K022690 |
| 510k Number | K022690 |
| Device Name: | PAROS CRP |
| Classification | System, Test, C-reactive Protein |
| Applicant | HORIBA LTD. 34 BUNSEN DR. Irvine, CA 92618 |
| Contact | Ian Giles |
| Correspondent | Ian Giles HORIBA LTD. 34 BUNSEN DR. Irvine, CA 92618 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-13 |
| Decision Date | 2002-12-23 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PAROS CRP 78165842 2921474 Dead/Cancelled |
HORIBA ABX SAS 2002-09-19 |