K810810 is an FDA 510(k) clearance for the AMICON ULTRAFILTRATION MEMBRANES CMII. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX).
Submitted by Amicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981, 24 days after receiving the submission on March 24, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K810810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1981 |
| Decision Date | April 17, 1981 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DHX — System, Test, Carcinoembryonic Antigen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.6010 |