The following data is part of a premarket notification filed by Biosystems S.a. with the FDA for Calcium-cresolphthalein, Glucose, Urea/bun-uv.
| Device ID | K192730 |
| 510k Number | K192730 |
| Device Name: | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV |
| Classification | Titrimetric With Edta And Indicator, Calcium |
| Applicant | BioSystems S.A. Costa Brava, 30 Barcelona, ES |
| Contact | Noelia Gil |
| Correspondent | Noelia Gil BioSystems S.A. Costa Brava, 30 Barcelona, ES |
| Product Code | CHW |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CGA |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-09-09 |