Rheumagen CRP T-Control
FDA 510(k) K904312 · Biokit USA, Inc.
510(k) numberK904312
Submission
- Device name
- Rheumagen CRP T-Control
- Applicant
- Biokit USA, Inc.
Barcelona, ES - Received
- September 19, 1990
- Decision date
- October 1, 1990
- 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
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 |
|---|---|---|
| K913467 | ToxogenLLA · Traditional | 01/11/1993SE |
| K910541 | Biokit RPRGMQ · Traditional | 10/18/1991SE |
| K904310 | Rheumagen RF T-ControlDHR · Traditional | 05/31/1991SE |
| K910539 | Rheumajet RFDHR · Traditional | 04/05/1991SE |
| K910686 | Rheumajet CRPDCN · Traditional | 03/19/1991SE |
| K904311 | Rheumagen Aso T-ControlGTQ · Traditional | 01/25/1991SE |
| K896433 | Modified RubagenLQN · Traditional | 11/29/1989SE |
| K896272 | Quantex CRP Plus (Latex, Buffer, Standard, ControlDCN · Traditional | 11/08/1989SE |
| K896271 | Quantex RF Plus (Latex, Buffer Standard, Control)DHR · Traditional | 11/08/1989SE |
| K894486 | Quantex Aso Plus (Latex,Buffer Standard,Control)GTQ · Traditional | 10/24/1989SE |
Questions and answers
When was Rheumagen CRP T-Control cleared by the FDA?
Rheumagen CRP T-Control (K904312) received a 510(k) decision of Substantially Equivalent on October 1, 1990, 12 days after the submission was received.
What is the product code of K904312?
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.