Control Plasma N
FDA 510(k) K023309 · Dade Behring, Inc.
510(k) numberK023309
Submission
- Device name
- Control Plasma N
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- October 3, 2002
- Decision date
- November 1, 2002
- 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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| K001256 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 05/24/2000SE |
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| 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 Control Plasma N cleared by the FDA?
Control Plasma N (K023309) received a 510(k) decision of Substantially Equivalent on November 1, 2002, 29 days after the submission was received.
What is the product code of K023309?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.