FDA 510(k) Applications for Medical Device Product Code "CFF"
(Immunoelectrophoretic, Immunoglobulins, (G, A, M))

FDA 510(k) Number Applicant Device Name Decision Date
K002799 BECKMAN COULTER, INC. PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 10/05/2000
K103757 GRIFOLS IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT 10/13/2011
K120169 GRIFOLS USA, LLC INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT 08/24/2012
K990998 HELENA LABORATORIES POLYSLIT IFE KIT 06/28/1999
K024162 HELENA LABORATORIES SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 02/19/2003
K061069 HELENA LABORATORIES SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 07/06/2006
K973040 HELENA LABORATORIES SPIFE IFE-6 01/02/1998
K111369 HELENA LABORATORIES UK LTD THE HELENA V8 IMMUNODISPLACEMENT KIT 06/26/2012
K033187 INTERLAB S.R.L. INTERLAB IMMUNOFIXATION TEST(S) 11/19/2003
K993213 KAMIYA BIOMEDICAL CO. K-ASSAY IGA 11/23/1999
K993323 KAMIYA BIOMEDICAL CO. K-ASSAY IGM 11/30/1999
K981048 MORAX HYDRAGEL 6 CSF KIT 10/07/1998
K033277 MORAX HYDRAGEL CSF ISOFOCUSING KITS 11/04/2003
K960669 MORAX HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS 07/12/1996
K192095 Sebia CAPI 3 Immunotyping, Capillarys 3 Tera 11/01/2019
K161928 Sebia CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL 12/21/2016
K082085 SEBIA CAPILLARYS IMMUNOTYPING, MODEL 2100 04/17/2009
K190851 Sebia HYDRASHIFT 2/4 daratumumab 05/02/2019
K172195 Sebia HYDRASHIFT 2/4 daratumumab, daratumumab Control 01/11/2018
K203184 Sebia HYDRASHIFT 2/4 isatuximab 11/12/2021
K143483 SEBIA MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING 01/08/2015
K082388 SEBIA MINICAP IMMUNOTYPING, MODEL: 2300 04/14/2009


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