K953211 is an FDA 510(k) clearance for the AMYLASE (ETHYLIDENE PNGPG7) KIT. This device is classified as a Saccharogenic, Amylase (Class II - Special Controls, product code CIJ).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 21, 1996, 347 days after receiving the submission on July 10, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K953211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1995 |
| Decision Date | June 21, 1996 |
| Days to Decision | 347 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 |