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
K823884 BECKMAN INSTRUMENTS, INC. PARAGON IMMUNOELECTROPHORESIS REAGENT 03/07/1983
K790667 CORNING MEDICAL & SCIENTIFIC CORNING PARAPROTEIN SCREENING 07/24/1979
K933972 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA IGG 03/22/1994
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
K923658 HELENA LABORATORIES REP IMMUNOFIX 11/02/1992
K892424 HELENA LABORATORIES REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 06/09/1989
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
K161928 Sebia CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL 12/21/2016
K082085 SEBIA CAPILLARYS IMMUNOTYPING, MODEL 2100 04/17/2009
K172195 Sebia HYDRASHIFT 2/4 daratumumab, daratumumab Control 01/11/2018
K143483 SEBIA MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING 01/08/2015
K082388 SEBIA MINICAP IMMUNOTYPING, MODEL: 2300 04/14/2009
K924769 THE BINDING SITE, LTD. IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC 02/23/1993
K924767 THE BINDING SITE, LTD. IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC 02/23/1993


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