K210633 is an FDA 510(k) clearance for the Amylase2. This device is classified as a Catalytic Methods, Amylase (Class II - Special Controls, product code JFJ).
Submitted by Abbott Ireland Diagnostics Division (Longsford, IE). The FDA issued a Cleared decision on May 26, 2022, 449 days after receiving the submission on March 3, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K210633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2021 |
| Decision Date | May 26, 2022 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFJ - Catalytic Methods, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |