The following data is part of a premarket notification filed by Biosystems S.a. with the FDA for Albumin, Alkaline Phosphatase (alp)-amp, Glucose-hexokinase, Ba400.
| Device ID | K170901 |
| 510k Number | K170901 |
| Device Name: | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | BioSystems S.A. Costa Brava, 30. Barcelona, ES E08030 |
| Contact | Teresa Maria Cortes |
| Correspondent | Teresa Maria Cortes BioSystems S.A. Costa Brava, 30. Barcelona, ES 08030 |
| Product Code | CIX |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CJE |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2018-04-13 |