Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit
FDA 510(k) K972220 · Randox Laboratories, Ltd.
510(k) numberK972220
Submission
- Device name
- Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit
- Applicant
- Randox Laboratories, Ltd.
Crumlin, Co. Antrim, IE - Received
- June 12, 1997
- Decision date
- September 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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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Questions and answers
When was Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit cleared by the FDA?
Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit (K972220) received a 510(k) decision of Substantially Equivalent on September 9, 1997, 89 days after the submission was received.
What is the product code of K972220?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.