Panels › Immunology › Product code CFF · Class 2
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Regulation 866.5510
0510(k)s in 12 months (29 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in CFF
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 6 | 2 |
| Sebia | 8 | 0 |
| Kamiya Biomedical Co. | 2 | 1 |
| Morax | 3 | 0 |
| Beckman Coulter, Inc. | 1 | 1 |
| The Binding Site, Ltd. | 2 | 0 |
| Grifols | 2 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Crestat Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 2021 | K203184 | HYDRASHIFT 2/4 isatuximab Sebia | CFF |
| Nov 1, 2019 | K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera Sebia | CFF |
| May 2, 2019 | K190851 | HYDRASHIFT 2/4 daratumumab Sebia | CFF |
| Jan 11, 2018 | K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control Sebia | CFF |
| Dec 21, 2016 | K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL Sebia | CFF |
| Jan 8, 2015 | K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING Sebia | CFF |
| Aug 24, 2012 | K120169 | INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT Grifols USA, LLC | CFF |
| Jun 26, 2012 | K111369 | THE HELENA V8 IMMUNODISPLACEMENT KIT Helena Laboratories Uk, Ltd. | CFF |
| Oct 13, 2011 | K103757 | IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT Grifols | CFF |
| Apr 17, 2009 | K082085 | CAPILLARYS IMMUNOTYPING, MODEL 2100 Sebia | CFF |
| Apr 14, 2009 | K082388 | MINICAP IMMUNOTYPING, MODEL: 2300 Sebia | CFF |
| Jul 6, 2006 | K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 Helena Laboratories | CFF |
| Nov 19, 2003 | K033187 | INTERLAB IMMUNOFIXATION TEST(S) Interlab S.R.L. | CFF |
| Nov 4, 2003 | K033277 | HYDRAGEL CSF ISOFOCUSING KITS Morax | CFF |
| Feb 19, 2003 | K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 Helena Laboratories | CFF |
| Oct 5, 2000 | K002799 | PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 Beckman Coulter, Inc. | CFF |
| Nov 30, 1999 | K993323 | K-ASSAY IGM Kamiya Biomedical Co. | CFF |
| Nov 23, 1999 | K993213 | K-ASSAY IGA Kamiya Biomedical Co. | CFF |
| Jun 28, 1999 | K990998 | POLYSLIT IFE KIT Helena Laboratories | CFF |
| Oct 7, 1998 | K981048 | HYDRAGEL 6 CSF KIT Morax | CFF |
| Jan 2, 1998 | K973040 | SPIFE IFE-6 Helena Laboratories | CFF |
| Jul 12, 1996 | K960669 | HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS Morax | CFF |
| Mar 22, 1994 | K933972 | N-ASSAY TIA IGG Crestat Diagnostics, Inc. | CFF |
| Feb 23, 1993 | K924769 | IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC The Binding Site, Ltd. | CFF |
| Feb 23, 1993 | K924767 | IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC The Binding Site, Ltd. | CFF |
| Nov 2, 1992 | K923658 | REP IMMUNOFIX Helena Laboratories | CFF |
| Jun 9, 1989 | K892424 | REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 Helena Laboratories | CFF |
| Mar 7, 1983 | K823884 | PARAGON IMMUNOELECTROPHORESIS REAGENT Beckman Instruments, Inc. | CFF |
| Jul 24, 1979 | K790667 | CORNING PARAPROTEIN SCREENING Corning Medical & Scientific | CFF |
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