K761100 is an FDA 510(k) clearance for the MULTI-CELL ULTRAFILTRATION SYSTEM. This device is classified as a Dialyzer (Class I — General Controls, product code JQQ).
Submitted by Amicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976, 13 days after receiving the submission on November 23, 1976.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K761100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1976 |
| Decision Date | December 06, 1976 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQQ — Dialyzer |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2050 |