Accutex CRP Latex Test
FDA 510(k) K924332 · J.S. Medical Assoc.
510(k) numberK924332
Submission
- Device name
- Accutex CRP Latex Test
- Applicant
- J.S. Medical Assoc.
Natick, MA, US - Received
- August 27, 1992
- Decision date
- December 7, 1992
- 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 |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K932752 | Visi-SpotJTO · Traditional | 11/05/1993SE |
| K932688 | Eye Spot Im TestKTN · Traditional | 09/08/1993SE |
| K932180 | Eye Spot CRP TestDCN · Traditional | 08/23/1993SE |
| K932551 | Accutex Im Latex TestKTN · Traditional | 08/09/1993SE |
| K926112 | Accutex Beta-Hcg TestJHJ · Traditional | 07/28/1993SE |
| K924247 | Accutex Aso Latex TestGTQ · Traditional | 12/07/1992SE |
| K924036 | Accutex Rheumatiod Factor (RF) Latex TestDHR · Traditional | 12/01/1992SE |
| K924248 | Accutex Sle Latex TestLJM · Traditional | 11/02/1992SE |
| K924037 | Accutex Im RBC TestKTN · Traditional | 11/02/1992SE |
| K912717 | J&S Uibc ReagentsJMO · Traditional | 09/25/1991SE |
Questions and answers
When was Accutex CRP Latex Test cleared by the FDA?
Accutex CRP Latex Test (K924332) received a 510(k) decision of Substantially Equivalent on December 7, 1992, 102 days after the submission was received.
What is the product code of K924332?
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.