Nycocard CRP
FDA 510(k) K013787 · Primus Corp.
510(k) numberK013787
Submission
- Device name
- Nycocard CRP
- Applicant
- Primus Corp.
Kansas City, MO, US - Received
- November 14, 2001
- Decision date
- May 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
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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 |
|---|---|---|
| K062658 | Primus A1CARE AssayLCP · Traditional | 11/26/2007SE |
| K014084 | Nycocard CRP ControlDCK · Traditional | 01/07/2002SE |
| K993131 | Nycocard HBA1C Glycosylated Hemoglobin AssayLCP · Traditional | 05/22/2000SE |
| K994045 | Primus Liquid Calibrator for GHB/A1C Level 1 and Level 2LCP · Special | 12/21/1999SE |
| K992921 | Primus Liquid Control for Ghb/Alc Level I and Level IILCP · Traditional | 11/12/1999SE |
| K955283 | Primus Variant System PVS99GKA · Traditional | 03/01/1996SE |
| K942009 | Primus Rapid Gel 100 Glycated Hemoglobin AssayLCP · Traditional | 09/14/1994SE |
| K940008 | Glycated Protein CalibratorsJIS · Traditional | 05/09/1994SE |
| K940142 | Glycated Protein ControlsJJX · Traditional | 04/26/1994SE |
| K936204 | Glycated Hemoglobin CalibratorsLCP · Traditional | 03/22/1994SE |
Questions and answers
When was Nycocard CRP cleared by the FDA?
Nycocard CRP (K013787) received a 510(k) decision of Substantially Equivalent on May 14, 2002, 181 days after the submission was received.
What is the product code of K013787?
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.