Liquispex(Tm) Liquid CRP Control Level 1 and 2
FDA 510(k) K946050 · Clinical Controls, Inc.
510(k) numberK946050
Submission
- Device name
- Liquispex(Tm) Liquid CRP Control Level 1 and 2
- Applicant
- Clinical Controls, Inc.
Grover Beach, CA, US - Received
- December 12, 1994
- Decision date
- February 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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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| K962432 | Liquispex Urine (Micro)Albumin ControlJJX · Traditional | 07/05/1996SE |
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| K946265 | Fibrinogen High Abnormal Control - Level 3GIL · Traditional | 08/24/1995SE |
| K935598 | Plasma Fibrinogen Control Level 1/LEVEL 2GIL · Traditional | 05/02/1995SE |
| K946266 | Ferritin Control - Level 1, 2, 3DGD · Traditional | 02/10/1995SE |
| K946049 | Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2JJY · Traditional | 02/10/1995SE |
| K946048 | Liquispex(Tm) Liquid B2M Control Level 1 and 2JZG · Traditional | 02/10/1995SE |
Questions and answers
When was Liquispex(Tm) Liquid CRP Control Level 1 and 2 cleared by the FDA?
Liquispex(Tm) Liquid CRP Control Level 1 and 2 (K946050) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 60 days after the submission was received.
What is the product code of K946050?
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.