Theratest El-Rfscr
FDA 510(k) K962050 · Theratest Laboratories, Inc.
510(k) numberK962050
Submission
- Device name
- Theratest El-Rfscr
- Applicant
- Theratest Laboratories, Inc.
Chicago, IL, US - Received
- May 28, 1996
- Decision date
- December 16, 1996
- 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 |
|---|---|---|
| K090753 | Theratest EL-ANTI-CCP/2NHX · Traditional | 03/05/2010SE |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | 09/03/2009SE |
| K071692 | Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test SystemsMVM · Traditional | 11/05/2007SE |
| K061376 | El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3MOB · Traditional | 07/20/2006SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | 02/07/2006SE |
| K051066 | Theratest El-Ana ProfilesLKP · Traditional | 10/07/2005SE |
| K040291 | El-Ana Profiles: Anti-ChromatinLJM · Traditional | 03/11/2004SE |
| K024151 | El-Ana Profiles: Anti-Ribosomal Protein PMQA · Traditional | 02/06/2003SE |
| K024031 | The Theratest El-Ana Profiles: Anti-CentromereLJM · Traditional | 02/06/2003SE |
| K002559 | El-Ana PROFILES-2K1LJM · Traditional | 09/12/2000SE |
Questions and answers
When was Theratest El-Rfscr cleared by the FDA?
Theratest El-Rfscr (K962050) received a 510(k) decision of Substantially Equivalent on December 16, 1996, 202 days after the submission was received.
What is the product code of K962050?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.