V-Trend Target CRP Test
FDA 510(k) K890423 · Texas Immunology, Inc.
510(k) numberK890423
Submission
- Device name
- V-Trend Target CRP Test
- Applicant
- Texas Immunology, Inc.
Tyler, TX, US - Received
- January 26, 1989
- Decision date
- February 17, 1989
- 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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| K192028 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 06/25/2020SE |
| 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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| K910073 | Target Aso TestGTQ · Traditional | 05/21/1991SE |
| K904105 | V-Trend Target RF TestDHR · Traditional | 10/15/1990SE |
| K892231 | V-Trend Target CRP TestDCN · Traditional | 04/21/1989SE |
| K890041 | V-Trend Target Im TestKTN · Traditional | 01/23/1989SE |
Questions and answers
When was V-Trend Target CRP Test cleared by the FDA?
V-Trend Target CRP Test (K890423) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 22 days after the submission was received.
What is the product code of K890423?
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.