The following data is part of a premarket notification filed by Biosystems S.a. with the FDA for Alpha-amylase Direct, Alpha-amylase Eps, Alpha-amylase Pancreatic, Bilirubin Direct, Bilirubin Total.
| Device ID | K182474 |
| 510k Number | K182474 |
| Device Name: | Alpha-AMYLASE DIRECT, Alpha-AMYLASE EPS, Alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL |
| Classification | Catalytic Methods, Amylase |
| Applicant | BioSystems S.A. Costa Brava, 30 Barcelona, ES 08030 |
| Contact | Noelia Gil |
| Correspondent | Noelia Gil BioSystems S.A. Costa Brava, 30 Barcelona, ES 08030 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2019-05-02 |