K172957 is an FDA 510(k) clearance for the Kawasumi Laboratories Blood Drawing Kit (BDK) System. This device is classified as a Set, Transfer (blood/plasma) (Class II - Special Controls, product code KSB).
Submitted by Kawasumi Laboratories, Inc. (Tokyo, JP). The FDA issued a Cleared decision on September 28, 2018, 367 days after receiving the submission on September 26, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 864.9875.
| 510(k) Number | K172957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2017 |
| Decision Date | September 28, 2018 |
| Days to Decision | 367 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KSB — Set, Transfer (blood/plasma) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9875 |