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 |