Control, Cell Counter, Normal And Abnormal
FDA product code JCN · Class II (moderate risk) · 21 CFR 864.8625 · Hematology
12510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993825 | Para Tech Plus ReticsJCN · Traditional | Streck Laboratories, Inc. | 11/30/1999SE |
| K942209 | Liquichek HEMATOLOGY-16 Control, Low, Normal and HighJCN · Traditional | Bio-Rad | 06/16/1994SE |
| K934497 | Cbc-Stk(Tm) Hematology Control/MultipleJCN · Traditional | R&D Systems, Inc. | 12/06/1993SE |
| K911582 | Stak-ChexJCN · Traditional | Streck Laboratories, Inc. | 05/28/1991SE |
| K902391 | Cell-Dyn 3000 ControlJCN · Traditional | Unipath , Ltd. | 08/22/1990SE |
| K902389 | Tri-Count 16JCN · Traditional | Hematronix, Inc. | 08/22/1990SE |
| K901875 | Para 12 PlusJCN · Traditional | Streck Laboratories, Inc. | 05/30/1990SE |
| K896154 | Para Tech for Technicon H-1JCN · Traditional | Streck Laboratories, Inc. | 11/09/1989SE |
| K895373 | Hematology ControlJCN · Traditional | Medical Specialties Intl., Inc. | 10/06/1989SE |
| K891907 | Qbc(R) Centrifugal Hematology Contr/Multi ModifiedJCN · Traditional | R&D Systems, Inc. | 04/11/1989SE |
| K874386 | Cbc-Tech(Tm) Hematology Control/MultipleJCN · Traditional | R&D Systems, Inc. | 12/30/1987SE |
| K821956 | Haem-C Plus Blood Reference ControlsJCN · Traditional | Baker Instructions Corp. | 07/30/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2089-2025 Class II | ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. | Siemens Healthcare Diagnostics, Inc. | 06/04/2025Open, Classified |
| Z-2088-2025 Class II | ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. | Siemens Healthcare Diagnostics, Inc. | 06/04/2025Open, Classified |
| Z-2087-2025 Class II | ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. | Siemens Healthcare Diagnostics, Inc. | 06/04/2025Open, Classified |