K810855 is an FDA 510(k) clearance for the INTERFACE 20 MICRON TRANSFUSION BLD. F.. This device is classified as a Microfilter, Blood Transfusion (Class II - Special Controls, product code CAK).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 21, 1981, 22 days after receiving the submission on March 30, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K810855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1981 |
| Decision Date | April 21, 1981 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | CAK — Microfilter, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |