K810669 is an FDA 510(k) clearance for the PANTRAK E.K.. This device is classified as a Starch-dye Bound Polymer, Amylase (Class II - Special Controls, product code CIW).
Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on March 31, 1981, 19 days after receiving the submission on March 12, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K810669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1981 |
| Decision Date | March 31, 1981 |
| Days to Decision | 19 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 |