K782032 is an FDA 510(k) clearance for the UNITEST AMYLASE. This device is classified as a Starch-dye Bound Polymer, Amylase (Class II - Special Controls, product code CIW).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1979, 86 days after receiving the submission on December 6, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K782032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1978 |
| Decision Date | March 02, 1979 |
| Days to Decision | 86 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 |