The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M.
| Device ID | K193525 |
| 510k Number | K193525 |
| Device Name: | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M |
| Classification | Iga, 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 | CZP |
| Subsequent Product Code | CFN |
| Subsequent Product Code | DEW |
| Subsequent Product Code | DFT |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-19 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230007365 | K193525 | 000 |
| 03610230007358 | K193525 | 000 |
| 03610230007334 | K193525 | 000 |