The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor.
| Device ID | K191562 |
| 510k Number | K191562 |
| Device Name: | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor |
| Classification | Ferritin, Antigen, Antiserum, 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 341184 |
| Product Code | DBF |
| Subsequent Product Code | DDG |
| Subsequent Product Code | DHR |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2020-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230007419 | K191562 | 000 |
| 03610230007402 | K191562 | 000 |
| 03610230007327 | K191562 | 000 |