K812697 is an FDA 510(k) clearance for the HEMA 20 MICRON TRANSFUSION BLOOD FILTER. 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 October 8, 1981, 16 days after receiving the submission on September 22, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K812697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 1981 |
| Decision Date | October 08, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | CAK — Microfilter, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |