Wide Range C-Reactive Protein (WR CRP) Assay
FDA 510(k) K041155 · Stanbio Laboratory
510(k) numberK041155
Submission
- Device name
- Wide Range C-Reactive Protein (WR CRP) Assay
- Applicant
- Stanbio Laboratory
Boerne, TX, US - Received
- May 3, 2004
- Decision date
- October 14, 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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| 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 Wide Range C-Reactive Protein (WR CRP) Assay cleared by the FDA?
Wide Range C-Reactive Protein (WR CRP) Assay (K041155) received a 510(k) decision of Substantially Equivalent on October 14, 2004, 164 days after the submission was received.
What is the product code of K041155?
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.