XN CAL
Calibrator For Cell Indices
Streck
The following data is part of a premarket notification filed by Streck with the FDA for Xn Cal.
Pre-market Notification Details
| Device ID | K160585 |
| 510k Number | K160585 |
| Device Name: | XN CAL |
| Classification | Calibrator For Cell Indices |
| Applicant | Streck 7002 S. 109th Street La Vista, NE 68128 |
| Contact | Deborah Kipp |
| Correspondent | Deborah Kipp Streck 7002 S. 109th Street La Vista, NE 68128 |
| Product Code | KRX |
| CFR Regulation Number | 864.8150 [🔎] |
| 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 |
Trademark Results [XN CAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XN CAL 85147651 4315467 Live/Registered |
Sysmex Corporation 2010-10-07 |
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