VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
FDA 510(k) K152433 · Ortho Clinical Diagnostics
510(k) numberK152433
Submission
- Device name
- VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
- Applicant
- Ortho Clinical Diagnostics
Rochester, NY, US - Received
- August 27, 2015
- Decision date
- September 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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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 |
| 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 |
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Questions and answers
When was VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 cleared by the FDA?
VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433) received a 510(k) decision of Substantially Equivalent on September 24, 2015, 28 days after the submission was received.
What is the product code of K152433?
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.