Dade Behring Heparin Calibrator and Controls
FDA 510(k) K042941 · Dade Behring, Inc.
510(k) numberK042941
Submission
- Device name
- Dade Behring Heparin Calibrator and Controls
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- October 25, 2004
- Decision date
- December 2, 2004
- 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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| 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 |
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Questions and answers
When was Dade Behring Heparin Calibrator and Controls cleared by the FDA?
Dade Behring Heparin Calibrator and Controls (K042941) received a 510(k) decision of Substantially Equivalent on December 2, 2004, 38 days after the submission was received.
What is the product code of K042941?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.