K931559 is an FDA 510(k) clearance for the DMA AMYLASE PROCEDURE. This device is classified as a Starch-dye Bound Polymer, Amylase (Class II - Special Controls, product code CIW).
Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on October 28, 1993, 212 days after receiving the submission on March 30, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K931559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1993 |
| Decision Date | October 28, 1993 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIW — Starch-dye Bound Polymer, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |