Plasma, Control, Normal
FDA product code GIZ · Class II (moderate risk) · 21 CFR 864.5425 · Hematology
20510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Dade Behring, Inc. 3
- Analytical Control Systems, Inc. 2
- Medical Diagnostic Technologies, Inc. 2
- Sigma Diagnostics, Inc. 2
- Creative Laboratory Products, Inc. 1
- Elite Diagnostic , Ltd. 1
- American Bioproducts Co. 1
- American Diagnostic Corp. 1
- Behring Diagnostics, Inc. 1
- American Diagnostica, Inc. 1
- Helena Laboratories 1
- Cardiovascular Diagnostics, Inc. 1
- Pacific Hemostasis 1
- Precision Biologic 1
- Wortham Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060968 | Stasis - I, II and III; Serathan - a, B; Intrin - Ea, Si Calcium Chloride 0.02M…GIZ · Traditional | Wortham Laboratories, Inc. | 05/15/2007SE |
| K042941 | Dade Behring Heparin Calibrator and ControlsGIZ · Traditional | Dade Behring, Inc. | 12/02/2004SE |
| K023309 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K013708 | Reference Check, Catalog NUMBER-RCN-10GIZ · Traditional | Precision Biologic | 12/10/2001SE |
| K003328 | Accuclot Control I, Model A4089GIZ · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
| K001256 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 05/24/2000SE |
| K984129 | Coagulation Control Level 1 (Normal)GIZ · Traditional | Pacific Hemostasis | 12/01/1998SE |
| K973274 | Accucolor High Calibrator (A3089)GIZ · Traditional | Sigma Diagnostics, Inc. | 10/31/1997SE |
| K961814 | Thrombolytic Assessment System Prothrombin Time Test ControlsGIZ · Traditional | Cardiovascular Diagnostics, Inc. | 08/13/1996SE |
| K941737 | Specialty Assayed CONTROL-1GIZ · Traditional | Helena Laboratories | 10/07/1994SE |
| K935254 | Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control PlasmaGIZ · Traditional | American Diagnostica, Inc. | 09/19/1994SE |
| K924403 | Control Plasma NGIZ · Traditional | Behring Diagnostics, Inc. | 02/22/1994SE |
| K932145 | Coagulation Reference Plasma, NormalGIZ · Traditional | American Diagnostic Corp. | 10/18/1993SE |
| K922021 | Unicalibrator KitGIZ · Traditional | American Bioproducts Co. | 06/09/1992SE |
| K905203 | Coagulation Reference Plasma, NormalGIZ · Traditional | Medical Diagnostic Technologies, Inc. | 12/28/1990SE |
| K895262 | Normal Coagulation Control Plasma (NCCP)GIZ · Traditional | Medical Diagnostic Technologies, Inc. | 10/06/1989SE |
| K893784 | Acs Human Plasma Coagulation Control Level IGIZ · Traditional | Analytical Control Systems, Inc. | 06/23/1989SE |
| K893783 | Acs Animal Plasma Coagulation Control Level IGIZ · Traditional | Analytical Control Systems, Inc. | 06/23/1989SE |
| K891179 | Edl Normal Coagulation ControlGIZ · Traditional | Elite Diagnostic , Ltd. | 04/10/1989SE |
| K880712 | CLP Normal Coagulation ControlGIZ · Traditional | Creative Laboratory Products, Inc. | 05/06/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0737-2020 Class II | STA UNICALIBRATOR (ref. 00675)A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA -… | Diagnostica Stago, Inc. | 11/18/2019Terminated |