The following data is part of a premarket notification filed by Streck with the FDA for Xn Check Bf.
| Device ID | K160588 |
| 510k Number | K160588 |
| Device Name: | XN CHECK BF |
| Classification | Mixture, Hematology Quality Control |
| Applicant | STRECK 7002 S. 109TH STREET La Vista, NE 68137 |
| Contact | Deborah Kipp |
| Correspondent | Deborah Kipp STRECK 7002 S. 109TH STREET La Vista, NE 68137 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-01 |
| Decision Date | 2016-12-22 |
| Summary: | summary |