Human C-Reactive Protein Rid Kit
FDA 510(k) K905633 · The Binding Site, Ltd.
510(k) numberK905633
Submission
- Device name
- Human C-Reactive Protein Rid Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- December 14, 1990
- Decision date
- July 22, 1991
- 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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| 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 |
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Questions and answers
When was Human C-Reactive Protein Rid Kit cleared by the FDA?
Human C-Reactive Protein Rid Kit (K905633) received a 510(k) decision of Substantially Equivalent on July 22, 1991, 220 days after the submission was received.
What is the product code of K905633?
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.