K833864 is an FDA 510(k) clearance for the AMYLASE REAGENT SET-MODIFIED CARAWAY. This device is classified as a Amyloclastic, Amylase (Class II - Special Controls, product code CJA).
Submitted by Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984, 67 days after receiving the submission on November 7, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K833864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1983 |
| Decision Date | January 13, 1984 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CJA — Amyloclastic, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |