The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Crp.
| Device ID | K191993 |
| 510k Number | K191993 |
| Device Name: | Yumizen C1200 CRP |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | Horiba ABX SAS Parc Euromedecine, Rue Du Caducee BP7290 Montpellier Cedex 4, FR 341184 |
| Contact | Caroline Ferrer |
| Correspondent | Caroline Ferrer Horiba ABX SAS Parc Euromedecine, Rue Du Caducee BP7290 Montpellier Cedex 4, FR 34184 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-25 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230007297 | K191993 | 000 |