Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma
FDA 510(k) K935254 · American Diagnostica, Inc.
510(k) numberK935254
Submission
- Device name
- Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma
- Applicant
- American Diagnostica, Inc.
Greenwich, CT, US - Received
- November 1, 1993
- Decision date
- September 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIZ – Plasma, Control, Normal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
Other 510(k)s with product code GIZ
| 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 |
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Questions and answers
When was Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma cleared by the FDA?
Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma (K935254) received a 510(k) decision of Substantially Equivalent on September 19, 1994, 322 days after the submission was received.
What is the product code of K935254?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.