Yumizen C1200 CRP
FDA 510(k) K191993 · Horiba Abx SAS
510(k) numberK191993
Submission
- Device name
- Yumizen C1200 CRP
- Applicant
- Horiba Abx SAS
Montpellier Cedex 4, FR - Received
- July 25, 2019
- Decision date
- October 3, 2019
- 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 |
| 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 |
| K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDCK · Traditional | Diazyme Laboratories | 04/27/2011SE |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K232946 | Yumizen H2500GKZ · Traditional | 05/21/2024SE |
| K193649 | Yumizen C1200 Creatinine PAPJFY · Traditional | 05/10/2021SE |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | 06/26/2020SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | 06/25/2020SE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF · Traditional | 03/06/2020SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | 08/30/2019SE |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY · Traditional | 07/26/2019SE |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CTGKZ · Traditional | 11/01/2017SE |
| K151133 | Pentra XLRGKZ · Traditional | 12/09/2015SE |
| K141161 | Abx Micros Es 60 CT; (Open Tube Model), (Close Tube Model)GKZ · Traditional | 12/20/2014SE |
Questions and answers
When was Yumizen C1200 CRP cleared by the FDA?
Yumizen C1200 CRP (K191993) received a 510(k) decision of Substantially Equivalent on October 3, 2019, 70 days after the submission was received.
What is the product code of K191993?
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.