Calibrator For Cell Indices
FDA product code KRX · Class II (moderate risk) · 21 CFR 864.8150 · Hematology
16510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160585 | XN CalKRX · Traditional | Streck | 12/22/2016SE |
| K141962 | XN CalKRX · Traditional | Streck | 12/05/2014SE |
| K141955 | XN Cal PFKRX · Traditional | Streck | 12/05/2014SE |
| K120747 | XN Cal PFKRX · Traditional | Streck | 10/22/2012SE |
| K120745 | XN CalKRX · Traditional | Streck | 10/19/2012SE |
| K111204 | Cell-Dyn 22 Plus CalibratorKRX · Traditional | Streck | 12/22/2011SE |
| K083200 | X-CalKRX · Traditional | Streck | 02/03/2009SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | Streck Laboratories, Inc. | 04/04/2002SE |
| K003991 | Cd-Cal Plus CalibratorKRX · Special | R&D Systems, Inc. | 01/16/2001SE |
| K993375 | CDS LTX Control Latex Particle Suspension and PrimerKRX · Abbreviated | Clinical Diagnostic Solutions, Inc. | 12/20/1999SE |
| K955925 | Cbc-Cal Plus Hematology CalibratorKRX · Traditional | R&D Systems, Inc. | 02/29/1996SE |
| K912357 | 3K-CAL Hematology Calibrator/MultipleKRX · Traditional | R&D Systems, Inc. | 07/09/1991SE |
| K862858 | Cbc-Cal (TM) Plus/MultipleKRX · Traditional | R&D Systems, Inc. | 08/21/1986SE |
| K831140 | Dade Hematology CalibratorKRX · Traditional | American Dade | 06/08/1983SE |
| K811741 | Cell-Chex RBCKRX · Traditional | Streck Laboratories, Inc. | 09/24/1981SE |
| K811063 | Laser-CalKRX · Traditional | Diagnostic Technology, Inc. | 07/01/1981SE |