The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for Kawasumi Laboratories Blood Drawing Kit (bdk) System.
| Device ID | K172957 |
| 510k Number | K172957 |
| Device Name: | Kawasumi Laboratories Blood Drawing Kit (BDK) System |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Kawasumi Laboratories, Inc. Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku Tokyo, JP 108-6109 |
| Contact | Takayuki Nakajima |
| Correspondent | Lisa L. Michels Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, WI 53158 |
| Product Code | KSB |
| Subsequent Product Code | FMI |
| Subsequent Product Code | LHI |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-09-28 |