K830014 is an FDA 510(k) clearance for the HEMA - NV TRANS. BLOOD FILTER 100/800. 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 January 17, 1983, 14 days after receiving the submission on January 3, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K830014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1983 |
| Decision Date | January 17, 1983 |
| Days to Decision | 14 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 |