The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Alp, Yumizen C1200 Albumin.
| Device ID | K191245 |
| 510k Number | K191245 |
| Device Name: | Yumizen C1200 ALP, Yumizen C1200 Albumin |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | HORIBA ABX SAS Parc Euromedecine Montpellier Cedex 4, FR 341184 |
| Contact | Caroline Ferrer |
| Correspondent | Caroline Ferrer HORIBA ABX SAS Parc Euromedecine Montpellier Cedex 4, FR 341184 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-09 |
| Decision Date | 2019-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006832 | K191245 | 000 |
| 03610230006825 | K191245 | 000 |