K070064 is an FDA 510(k) clearance for the AMYLASE EPS REAGENT. This device is classified as a Catalytic Methods, Amylase (Class II - Special Controls, product code JFJ).
Submitted by Thermo Fisher Scientific (Noble Park, AU). The FDA issued a Cleared decision on May 22, 2007, 137 days after receiving the submission on January 5, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K070064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2007 |
| Decision Date | May 22, 2007 |
| Days to Decision | 137 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 |