N-Geneous Wide Range CRP Reagent and Calibrator Set
FDA 510(k) K040241 · Genzyme Corp.
510(k) numberK040241
Submission
- Device name
- N-Geneous Wide Range CRP Reagent and Calibrator Set
- Applicant
- Genzyme Corp.
Cambridge, MA, US - Received
- February 3, 2004
- Decision date
- June 25, 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
Other 510(k)s with product code DCK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | Kamiya Biomedical Company, LLC | 04/18/2025SE |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK · Traditional | Procise Diagnostics | 11/04/2022SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 06/25/2020SE |
| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
| K191993 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 10/03/2019SE |
| 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 |
|---|---|---|
| K102242 | Osom C. Difficile Toxin A/B TestLLH · Traditional | 12/21/2010SE |
| K092633 | Osom Influenza A&B Test , Model PN190PSZ · Special | 09/25/2009SE |
| K080662 | Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorNDY · Traditional | 05/15/2008SE |
| K063739 | Sepramesh, Model 5959-1214FTL · Traditional | 01/17/2007SE |
| K061508 | Osom Influenza A&B TestPSZ · Traditional | 06/12/2006SE |
| K051244 | Genzyme Osom Influenza a & B TestPSZ · Traditional | 02/21/2006SE |
| K053066 | Sepramesh Ip Bioresorbable Coating/Permanent MeshFTL · Traditional | 12/19/2005SE |
| K043035 | Sepragel ENT Bioresorbable Packing/StentKHJ · Traditional | 07/11/2005SE |
| K040868 | Sepramesh Ip Bioresorbable Barrier - Permanent MeshFTM · Traditional | 06/04/2004SE |
| K033864 | Genzyme Osom Trichomonas Rapid TestJWZ · Traditional | 04/02/2004SE |
Questions and answers
When was N-Geneous Wide Range CRP Reagent and Calibrator Set cleared by the FDA?
N-Geneous Wide Range CRP Reagent and Calibrator Set (K040241) received a 510(k) decision of Substantially Equivalent on June 25, 2004, 143 days after the submission was received.
What is the product code of K040241?
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.