The following data is part of a premarket notification filed by Abbott Ireland Diagnostics Division with the FDA for Amylase2.
| Device ID | K210633 |
| 510k Number | K210633 |
| Device Name: | Amylase2 |
| Classification | Catalytic Methods, Amylase |
| Applicant | Abbott Ireland Diagnostics Division Lisnarnuck Longford, IE |
| Contact | Magdalena Suszko |
| Correspondent | Magdalena Suszko Abbott Ireland Diagnostics Division Lisnarnuck Longford, IE |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-03 |
| Decision Date | 2022-05-26 |