FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
FDA 510(k) K141689 · Qualigen, Inc.
510(k) numberK141689
Submission
- Device name
- FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
- Applicant
- Qualigen, Inc.
Carlsbad, CA, US - Received
- June 23, 2014
- Decision date
- January 7, 2015
- 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 |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
| K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDCK · Traditional | Diazyme Laboratories | 04/27/2011SE |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional | 01/29/2019SE |
| K123983 | Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersMRG · Traditional | 07/03/2013SE |
| K123725 | Fastpack Control KitJJY · Traditional | 03/08/2013SE |
| K101388 | Fastpack Testo ImmunoassayCDZ · Special | 02/18/2011SE |
| K101390 | Fastpack TSH ImmunoassayJLW · Special | 08/13/2010SE |
| K072264 | Fastpack HCG ImmunoassayJHI · Traditional | 12/06/2007SE |
| K062957 | Fastpack Total Psa Method Verification KitJJX · Abbreviated | 04/02/2007SE |
| K052301 | Fastpack TSH ImmunoassayJLW · Traditional | 01/04/2006SE |
| K030329 | Fastpack Free T4 ImmunoassayCEC · Traditional | 07/03/2003SE |
| K022533 | Fastpack Testosterone CalibratorJIT · Abbreviated | 09/30/2002SE |
Questions and answers
When was FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit cleared by the FDA?
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (K141689) received a 510(k) decision of Substantially Equivalent on January 7, 2015, 198 days after the submission was received.
What is the product code of K141689?
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.