K182474 is an FDA 510(k) clearance for the alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL. This device is classified as a Catalytic Methods, Amylase (Class II - Special Controls, product code JFJ).
Submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on May 2, 2019, 234 days after receiving the submission on September 10, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K182474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2018 |
| Decision Date | May 02, 2019 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JFJ - Catalytic Methods, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |