CFF — Immunoelectrophoretic, Immunoglobulins, (G, A, M) Class II
FDA product code CFF covers "Immunoelectrophoretic, Immunoglobulins, (G, A, M)", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFF
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203184 | sebia | HYDRASHIFT 2/4 isatuximab | November 12, 2021 |
| K192095 | sebia | CAPI 3 Immunotyping, Capillarys 3 Tera | November 1, 2019 |
| K190851 | sebia | HYDRASHIFT 2/4 daratumumab | May 2, 2019 |
| K172195 | sebia | HYDRASHIFT 2/4 daratumumab, daratumumab Control | January 11, 2018 |
| K161928 | sebia | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | December 21, 2016 |
| K143483 | sebia | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | January 8, 2015 |
| K120169 | grifols usa | INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT | August 24, 2012 |
| K111369 | helena laboratories uk | THE HELENA V8 IMMUNODISPLACEMENT KIT | June 26, 2012 |
| K103757 | grifols | IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT | October 13, 2011 |
| K082085 | sebia | CAPILLARYS IMMUNOTYPING, MODEL 2100 | April 17, 2009 |
| K082388 | sebia | MINICAP IMMUNOTYPING, MODEL: 2300 | April 14, 2009 |
| K061069 | helena laboratories | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S | July 6, 2006 |
| K033187 | interlab | INTERLAB IMMUNOFIXATION TEST(S) | November 19, 2003 |
| K033277 | morax | HYDRAGEL CSF ISOFOCUSING KITS | November 4, 2003 |
| K024162 | helena laboratories | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | February 19, 2003 |
| K002799 | beckman coulter | PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 | October 5, 2000 |
| K993323 | kamiya biomedical | K-ASSAY IGM | November 30, 1999 |
| K993213 | kamiya biomedical | K-ASSAY IGA | November 23, 1999 |
| K990998 | helena laboratories | POLYSLIT IFE KIT | June 28, 1999 |
| K981048 | morax | HYDRAGEL 6 CSF KIT | October 7, 1998 |