Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp)
FDA 510(k) K040579 · Cholestech Corp.
510(k) numberK040579
Submission
- Device name
- Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp)
- Applicant
- Cholestech Corp.
Hayward, CA, US - Received
- March 4, 2004
- Decision date
- June 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| 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 |
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Questions and answers
When was Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp) cleared by the FDA?
Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp) (K040579) received a 510(k) decision of Substantially Equivalent on June 18, 2004, 106 days after the submission was received.
What is the product code of K040579?
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.