Abbott Liquid RF Control, Models 2E04-01, 2E05-01, 2E06-01
FDA 510(k) K990587 · Bio-Rad
510(k) numberK990587
Submission
- Device name
- Abbott Liquid RF Control, Models 2E04-01, 2E05-01, 2E06-01
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- February 23, 1999
- Decision date
- April 7, 1999
- 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
Other 510(k)s with product code DHR
| 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 |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Abbott Liquid RF Control, Models 2E04-01, 2E05-01, 2E06-01 cleared by the FDA?
Abbott Liquid RF Control, Models 2E04-01, 2E05-01, 2E06-01 (K990587) received a 510(k) decision of Substantially Equivalent on April 7, 1999, 43 days after the submission was received.
What is the product code of K990587?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.