The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Calcium As, Yumizen C1200 Creatinine Jaffe.
| Device ID | K191396 |
| 510k Number | K191396 |
| Device Name: | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe |
| Classification | Azo Dye, Calcium |
| 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 | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-24 |
| Decision Date | 2019-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230008607 | K191396 | 000 |
| 03610230006955 | K191396 | 000 |