Panels › Hematology › Product code KRX · Class 2
Calibrator For Cell Indices
Regulation 864.8150
0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KRX
| Company | 510(k)s | Recalls |
|---|---|---|
| Streck | 7 | 0 |
| R&D Systems, Inc. | 4 | 0 |
| Streck Laboratories, Inc. | 2 | 0 |
| American Dade | 1 | 0 |
| Clinical Diagnostic Solutions, Inc. | 1 | 0 |
| Diagnostic Technology, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2016 | K160585 | XN CAL Streck | KRX |
| Dec 5, 2014 | K141962 | XN CAL Streck | KRX |
| Dec 5, 2014 | K141955 | XN CAL PF Streck | KRX |
| Oct 22, 2012 | K120747 | XN CAL PF Streck | KRX |
| Oct 19, 2012 | K120745 | XN CAL Streck | KRX |
| Dec 22, 2011 | K111204 | CELL-DYN 22 PLUS CALIBRATOR Streck | KRX |
| Feb 3, 2009 | K083200 | X-CAL Streck | KRX |
| Apr 4, 2002 | K020469 | CAL-CHEX CD PLUS Streck Laboratories, Inc. | KRX |
| Jan 16, 2001 | K003991 | CD-CAL PLUS CALIBRATOR R&D Systems, Inc. | KRX |
| Dec 20, 1999 | K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER Clinical Diagnostic Solutions, Inc. | KRX |
| Feb 29, 1996 | K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR R&D Systems, Inc. | KRX |
| Jul 9, 1991 | K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE R&D Systems, Inc. | KRX |
| Aug 21, 1986 | K862858 | CBC-CAL (TM) PLUS/MULTIPLE R&D Systems, Inc. | KRX |
| Jun 8, 1983 | K831140 | DADE HEMATOLOGY CALIBRATOR American Dade | KRX |
| Sep 24, 1981 | K811741 | CELL-CHEX RBC Streck Laboratories, Inc. | KRX |
| Jul 1, 1981 | K811063 | LASER-CAL Diagnostic Technology, Inc. | KRX |
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