Dupont Dimension C-Reactive Protein Method
FDA 510(k) K945280 · Dupont Medical Products
510(k) numberK945280
Submission
- Device name
- Dupont Dimension C-Reactive Protein Method
- Applicant
- Dupont Medical Products
Wilmington, DE, US - Received
- October 28, 1994
- Decision date
- March 9, 1995
- 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
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| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K952815 | Dupont Lipase CalibratorJIT · Traditional | 08/31/1995SE |
| K950920 | Dupont Dimension Total Protein MethodCEK · Traditional | 08/11/1995SE |
| K952816 | Lipase Flex Reagent CartridgeCHI · Traditional | 07/20/1995SE |
| K952412 | Dupont Aca(R) Urine Druge Os Abuse ControlDIF · Traditional | 06/23/1995SE |
| K944932 | Phenobarbital Flex Reagent CartridgeDLZ · Traditional | 12/28/1994SE |
| K941050 | Dupont Aca StarJJQ · Traditional | 11/10/1994SE |
| K943996 | Dupont Aca Plus Luteinizing Hormone (LH) MethodCEP · Traditional | 10/20/1994SE |
| K941146 | Dupont Aca Plus Thyroid Stimulating Hormone SystemJLW · Traditional | 10/03/1994SE |
| K942640 | Dupont Dimension Amylase MethodJFJ · Traditional | 09/09/1994SE |
| K942241 | Dupont Apc Blood Collection Container with ThromboplastinJKA · Traditional | 08/18/1994SE |
Questions and answers
When was Dupont Dimension C-Reactive Protein Method cleared by the FDA?
Dupont Dimension C-Reactive Protein Method (K945280) received a 510(k) decision of Substantially Equivalent on March 9, 1995, 132 days after the submission was received.
What is the product code of K945280?
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.