Mdi RF Test
FDA 510(k) K993843 · Micro Detect, Inc.
510(k) numberK993843
Submission
- Device name
- Mdi RF Test
- Applicant
- Micro Detect, Inc.
Tustin, CA, US - Received
- November 12, 1999
- Decision date
- January 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K003794 | Elisa Test, SerologyLYR · Traditional | 03/30/2001SE |
| K002359 | Mdi Gliadin G TestMST · Traditional | 10/19/2000SE |
| K002358 | Mdi Gliadin a TestMST · Traditional | 10/19/2000SE |
| K000934 | Mdi SCL-70 TestLJM · Traditional | 04/07/2000SE |
| K000477 | Mdi Ds-Dna TestLRM · Traditional | 03/01/2000SE |
| K994029 | Mdi SM TestLLL · Traditional | 01/11/2000SE |
| K993971 | Mdi Ss-B Test Enzyme Immunoassay for the Detection of Autoantibodies to Ss-B in Human…LLL · Traditional | 01/11/2000SE |
| K993636 | Mdi Ss-A TestLJM · Traditional | 01/10/2000SE |
| K993635 | Mdi Sm/Rnp TestLJM · Traditional | 01/10/2000SE |
| K973508 | Pylori Detect IggLYR · Traditional | 03/10/1998SE |
Questions and answers
When was Mdi RF Test cleared by the FDA?
Mdi RF Test (K993843) received a 510(k) decision of Substantially Equivalent on January 11, 2000, 60 days after the submission was received.
What is the product code of K993843?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.