K023396 is an FDA 510(k) clearance for the AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS). This device is classified as a Saccharogenic, Amylase (Class II - Special Controls, product code CIJ).
Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on December 23, 2002, 75 days after receiving the submission on October 9, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K023396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2002 |
| Decision Date | December 23, 2002 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIJ — Saccharogenic, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |