K011145 is an FDA 510(k) clearance for the MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658. This device is classified as a Catalytic Methods, Amylase (Class II - Special Controls, product code JFJ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 25, 2001, 91 days after receiving the submission on March 26, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K011145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2001 |
| Decision Date | June 25, 2001 |
| Days to Decision | 91 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 |