K850639 is an FDA 510(k) clearance for the ENZYMATIC ALPHA-AMYLASE REAGENT KIT. This device is classified as a Starch-dye Bound Polymer, Amylase (Class II - Special Controls, product code CIW).
Submitted by Bio-Analytics Laboratories, Inc. (Palm City, US). The FDA issued a Cleared decision on March 5, 1985, 14 days after receiving the submission on February 19, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K850639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1985 |
| Decision Date | March 05, 1985 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIW — Starch-dye Bound Polymer, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |