SPQ Test System for C-Reactive Protein
FDA 510(k) K850590 · Applications Lab
510(k) numberK850590
Submission
- Device name
- SPQ Test System for C-Reactive Protein
- Applicant
- Applications Lab
Scarborough, ME, US - Received
- February 13, 1985
- Decision date
- March 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
|---|---|---|
| K850587 | SPQ Test System for Alpha, - AntitrypsinDEM · Traditional | 03/14/1985SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | 03/14/1985SE |
| K850603 | SPQ Test System for ALPHA(2) MacroglobulinDEB · Traditional | 03/05/1985SE |
| K850589 | SPQ Test System for TransferrinDDG · Traditional | 03/05/1985SE |
| K850588 | SPQ Test System for Complement C3CZW · Traditional | 03/05/1985SE |
| K850584 | SPQ Test System for HaptoglobinDAD · Traditional | 03/05/1985SE |
| K850585 | SPQ Test System for Complement C4DBI · Traditional | 03/01/1985SE |
| K850583 | SPQ Test System for Immunoglobulin GDEW · Traditional | 03/01/1985SE |
| K850582 | SPQ Test System for Immunoglobulin aCZP · Traditional | 03/01/1985SE |
Questions and answers
When was SPQ Test System for C-Reactive Protein cleared by the FDA?
SPQ Test System for C-Reactive Protein (K850590) received a 510(k) decision of Substantially Equivalent on March 1, 1985, 16 days after the submission was received.
What is the product code of K850590?
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.