Turbox Rheumatoid Factor Immunological Test System
FDA 510(k) K884180 · Unipath , Ltd.
510(k) numberK884180
Submission
- Device name
- Turbox Rheumatoid Factor Immunological Test System
- Applicant
- Unipath , Ltd.
Bedford Mk41 Oqg, GB - Received
- September 30, 1988
- Decision date
- February 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHR – System, Test, Rheumatoid Factor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5775
- Specialty
- Immunology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional | Kamiya Biomedical Company | 05/20/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | Inova Diagnostics, Inc. | 04/17/2019SE |
| K182747 | EliA RF IgM ImmunoassayDHR · Traditional | Phadia AB | 12/18/2018SE |
| K162263 | Optilite Rheumatoid Factor KitDHR · Traditional | The Binding Site Group , Ltd. | 05/03/2017SE |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR · Traditional | The Binding Site Group , Ltd. | 12/07/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | Immco Diagnostics, Inc. | 09/23/2015SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | Phadia US, Inc. | 09/30/2011SE |
| K100499 | Orgentec Rheumatoid Factor EiaDHR · Traditional | Orgentec Diagnostika GmbH | 10/27/2010SE |
| K083080 | Igx Plex Rheumatoid Arthritis (Ra) Assay and Sqidworks Diagnostics PlatformDHR · Traditional | Sqi Diagnostics Systems | 10/29/2009SE |
| K071247 | N Latex RF KitDHR · Traditional | Dade Behring, Inc. | 08/08/2007SE |
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| K041404 | Clearblue Easy Easy Read Pregnancy TestLCX · Special | 06/08/2004SE |
| K040341 | Clearblue Easy Earliest Results Pregnancy TestLCX · Special | 03/08/2004SE |
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Questions and answers
When was Turbox Rheumatoid Factor Immunological Test System cleared by the FDA?
Turbox Rheumatoid Factor Immunological Test System (K884180) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 126 days after the submission was received.
What is the product code of K884180?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.