K904223 is an FDA 510(k) clearance for the SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS. This device is classified as a Microfilter, Blood Transfusion (Class II - Special Controls, product code CAK).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on October 26, 1990, 43 days after receiving the submission on September 13, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K904223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1990 |
| Decision Date | October 26, 1990 |
| Days to Decision | 43 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 |