Reaads-Rf Test Kit-Semiquantitative
FDA 510(k) K892445 · Biosearch Medical Products, Inc.
510(k) numberK892445
Submission
- Device name
- Reaads-Rf Test Kit-Semiquantitative
- Applicant
- Biosearch Medical Products, Inc.
Arlington, VA, US - Received
- April 10, 1989
- Decision date
- June 5, 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
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 |
|---|---|---|
| K051480 | Enteral Feeding TubeBSS · Traditional | 10/12/2005SE |
| K970145 | Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe)HIR · Traditional | 08/11/1997SE |
| K964871 | Biosearch Syring Flushing/Cleaning Pump for Biosearch Endoscopic InstrumentsFEB · Traditional | 03/03/1997SE |
| K951260 | Urinary Intermittent Catheters W/O Hydromer Hydrophilic LubricantKOD · Traditional | 09/27/1995SE |
| K944614 | Mega-Brush, Endoscopic Mass Cytology - Celluar Retrieval SystemFDX · Traditional | 04/05/1995SE |
| K932295 | Non-Balloon Replacement Gastrostomy KitKNT · Traditional | 09/08/1994SE |
| K935045 | Biosearch Laproscopic Gastronomy CatheterKNT · Traditional | 08/19/1994SE |
| K923002 | Enteroclysis TubeKNT · Traditional | 06/28/1994SESK |
| K934193 | Cell-Mate(Tm) Mass Cytology-Cellular Retrieval SystEOX · Traditional | 11/19/1993SE |
| K922987 | Lapstick Laparoscopic Sponge Stick/ Blunt Dissec.GCJ · Traditional | 04/23/1993SE |
Questions and answers
When was Reaads-Rf Test Kit-Semiquantitative cleared by the FDA?
Reaads-Rf Test Kit-Semiquantitative (K892445) received a 510(k) decision of Substantially Equivalent on June 5, 1989, 56 days after the submission was received.
What is the product code of K892445?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.