Radial Immuno-Test for Human C-Reacti
FDA 510(k) K831958 · Kent Laboratories, Inc.
510(k) numberK831958
Submission
- Device name
- Radial Immuno-Test for Human C-Reacti
- Applicant
- Kent Laboratories, Inc.
Mchenry, IL, US - Received
- June 17, 1983
- Decision date
- July 19, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K160712 | VITROS Chemistry Products hsCRP ReagentDCK · Traditional | Ortho Clinical Diagnostics | 07/14/2017SE |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | Orion Diagnostica, OY | 03/10/2016SE |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7DCK · Special | Ortho Clinical Diagnostics | 09/24/2015SE |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K951966 | Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional | 06/01/1995SE |
| K951968 | Human C1Q Radial Immunodiffusion KitDAK · Traditional | 05/30/1995SE |
| 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 |
Questions and answers
When was Radial Immuno-Test for Human C-Reacti cleared by the FDA?
Radial Immuno-Test for Human C-Reacti (K831958) received a 510(k) decision of Substantially Equivalent on July 19, 1983, 32 days after the submission was received.
What is the product code of K831958?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.