HYDRASHIFT 2/4 daratumumab
FDA 510(k) K190851 · Sebia
510(k) numberK190851
Submission
- Device name
- HYDRASHIFT 2/4 daratumumab
- Applicant
- Sebia
Norcross, GA, US - Received
- April 2, 2019
- Decision date
- May 2, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CFF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | Sebia | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | Sebia | 11/01/2019SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | Sebia | 01/11/2018SE |
| K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, It/If ControlCFF · Traditional | Sebia | 12/21/2016SE |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGCFF · Special | Sebia | 01/08/2015SE |
| K120169 | Interlab Ife Test Using G 26 Ver. 2.0 InstrumentCFF · Traditional | Grifols USA, LLC | 08/24/2012SE |
| K111369 | The Helena V8 Immunodisplacement KitCFF · Traditional | Helena Laboratories Uk, Ltd. | 06/26/2012SE |
| K103757 | Immunofixation Electrophoresis Test Using Interlab G26 InstrumentCFF · Traditional | Grifols | 10/13/2011SE |
| K082085 | Capillarys Immunotyping, Model 2100CFF · Traditional | Sebia | 04/17/2009SE |
| K082388 | Minicap Immunotyping, Model: 2300CFF · Traditional | Sebia | 04/14/2009SE |
More from Sebia
| 510(k) | Device | Decision |
|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | 04/04/2024SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | 02/23/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | 11/18/2022SE |
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | 11/01/2019SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | 12/14/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | 02/07/2018SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | 01/11/2018SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | 09/12/2017SE |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)LCP · Traditional | 02/17/2017SE |
Questions and answers
When was HYDRASHIFT 2/4 daratumumab cleared by the FDA?
HYDRASHIFT 2/4 daratumumab (K190851) received a 510(k) decision of Substantially Equivalent on May 2, 2019, 30 days after the submission was received.
What is the product code of K190851?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.