K933682 is an FDA 510(k) clearance for the DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS. This device is classified as a Catalytic Methods, Amylase (Class II - Special Controls, product code JFJ).
Submitted by Miles, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 12, 1994, 257 days after receiving the submission on July 29, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K933682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1993 |
| Decision Date | April 12, 1994 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFJ — Catalytic Methods, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |