Coagulation Reference Plasma, Normal
FDA 510(k) K932145 · American Diagnostic Corp.
510(k) numberK932145
Submission
- Device name
- Coagulation Reference Plasma, Normal
- Applicant
- American Diagnostic Corp.
Greenwich, CT, US - Received
- May 4, 1993
- Decision date
- October 18, 1993
- 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
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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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Questions and answers
When was Coagulation Reference Plasma, Normal cleared by the FDA?
Coagulation Reference Plasma, Normal (K932145) received a 510(k) decision of Substantially Equivalent on October 18, 1993, 167 days after the submission was received.
What is the product code of K932145?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.