XN CHECK
Mixture, Hematology Quality Control
STRECK
The following data is part of a premarket notification filed by Streck with the FDA for Xn Check.
Pre-market Notification Details
| Device ID | K160590 |
| 510k Number | K160590 |
| Device Name: | XN CHECK |
| Classification | Mixture, Hematology Quality Control |
| 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 | 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987562502766 | K160590 | 000 |
| 14987562502759 | K160590 | 000 |
| 14987562502742 | K160590 | 000 |
Trademark Results [XN CHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XN CHECK 85147679 4315470 Live/Registered |
Sysmex Corporation 2010-10-07 |
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