Human C1Q Radial Immunodiffusion Kit
FDA 510(k) K951968 · Kent Laboratories, Inc.
510(k) numberK951968
Submission
- Device name
- Human C1Q Radial Immunodiffusion Kit
- Applicant
- Kent Laboratories, Inc.
Redmond, WA, US - Received
- April 27, 1995
- Decision date
- May 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAK – Complement C1q, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
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More from Cytotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951966 | Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional | 06/01/1995SE |
| K951967 | Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion KitDBA · Traditional | 05/30/1995SE |
| K950102 | Human C-5 Radial Immunodiffusion KitDAY · Traditional | 04/10/1995SE |
| K850683 | 72 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional | 11/27/1985SE |
| K850682 | 72 Determ. Size Radial Immuno. Test Human CeruloplDDB · Traditional | 11/25/1985SE |
| K850691 | Antiserum to Human Apolipoprotein A-IMSJ · Traditional | 11/01/1985SE |
| K850690 | Antiserum to Human Apolipoprotein BMSJ · Traditional | 11/01/1985SE |
| K850686 | Antiserum to Human PrealbuminJZJ · Traditional | 11/01/1985SE |
| K831961 | Immunodiffusion Test Human AntithrombinJBQ · Traditional | 08/11/1983SE |
| K831960 | Test for Human Alpha One Acid Glyco-LKL · Traditional | 07/19/1983SE |
Questions and answers
When was Human C1Q Radial Immunodiffusion Kit cleared by the FDA?
Human C1Q Radial Immunodiffusion Kit (K951968) received a 510(k) decision of Substantially Equivalent on May 30, 1995, 33 days after the submission was received.
What is the product code of K951968?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.