The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for Kawasumi Multiple Sample Adapter With Pre-attached Holder (mbch).
| Device ID | K190485 |
| 510k Number | K190485 |
| Device Name: | Kawasumi Multiple Sample Adapter With Pre-Attached Holder (MBCH) |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Kawasumi Laboratories, Inc. Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku Tokyo, JP 108-6109 |
| Contact | Katsu Furuya |
| Correspondent | Lisa L. Michels Regulatory Compliance Associates, Inc. (RCA) 10411 Corporate Drive, Suite 102 Pleasant Prairie, WI 53158 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-07-08 |