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 |