Control Plasma N
FDA 510(k) K924403 · Behring Diagnostics, Inc.
510(k) numberK924403
Submission
- Device name
- Control Plasma N
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- August 31, 1992
- Decision date
- February 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GIZ – Plasma, Control, Normal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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|---|---|---|---|
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| 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 |
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| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
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Questions and answers
When was Control Plasma N cleared by the FDA?
Control Plasma N (K924403) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 540 days after the submission was received.
What is the product code of K924403?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.