K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
FDA 510(k) K192727 · Kamiya Biomedical Company
510(k) numberK192727
Submission
- Device name
- K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
- Applicant
- Kamiya Biomedical Company
Tukwila, WA, US - Received
- September 27, 2019
- Decision date
- May 20, 2020
- 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 |
|---|---|---|---|
| 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 |
| K060201 | Olympus RF Latex Calibrator, and Olympus RF Latex Reagent with Model(S): ODC0028, and…DHR · Traditional | Olympus America, Inc. | 06/06/2006SE |
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| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | 04/18/2025SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | 09/28/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
| K022486 | K-Assay Hs-Crp ControlsDCK · Traditional | 08/14/2002SE |
Questions and answers
When was K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) cleared by the FDA?
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (K192727) received a 510(k) decision of Substantially Equivalent on May 20, 2020, 236 days after the submission was received.
What is the product code of K192727?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.