K223810 is an FDA 510(k) clearance for the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH). This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Sb-Kawasumi Laboratories, Inc. (Kawasaki-Shi, JP). The FDA issued a Cleared decision on February 24, 2023, 66 days after receiving the submission on December 20, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K223810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2022 |
| Decision Date | February 24, 2023 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |