The following data is part of a premarket notification filed by Streck with the FDA for Xn Cal.
Device ID | K120745 |
510k Number | K120745 |
Device Name: | XN CAL |
Classification | Calibrator For Cell Indices |
Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
Contact | Deborah S Kipp |
Correspondent | Deborah S Kipp Streck 7002 SOUTH 109TH ST. Omaha, 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 | 2012-03-12 |
Decision Date | 2012-10-19 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XN CAL 85147651 4315467 Live/Registered |
Sysmex Corporation 2010-10-07 |