The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Creatinine Pap.
| Device ID | K193649 |
| 510k Number | K193649 |
| Device Name: | Yumizen C1200 Creatinine PAP |
| Classification | Enzymatic Method, Creatinine |
| 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 | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2021-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006962 | K193649 | 000 |