Atlas FDA

CFF

29 FDA 510(k) clearances · Product code

109 daysmedian time to decision
294 days90th percentile
29clearances measured

FDA profile

Official device name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
HYDRASHIFT 2/4 isatuximab (K203184)Sebia2021-11-12
CAPI 3 Immunotyping, Capillarys 3 Tera (K192095)Sebia2019-11-01
HYDRASHIFT 2/4 daratumumab (K190851)Sebia2019-05-02
HYDRASHIFT 2/4 daratumumab, daratumumab Control (K172195)Sebia2018-01-11
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL (K161928)Sebia2016-12-21
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (K143483)Sebia2015-01-08
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT (K120169)Grifols USA, LLC2012-08-24
THE HELENA V8 IMMUNODISPLACEMENT KIT (K111369)Helena Laboratories Uk, Ltd.2012-06-26
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT (K103757)Grifols2011-10-13
CAPILLARYS IMMUNOTYPING, MODEL 2100 (K082085)Sebia2009-04-17
MINICAP IMMUNOTYPING, MODEL: 2300 (K082388)Sebia2009-04-14
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 (K061069)Helena Laboratories2006-07-06
INTERLAB IMMUNOFIXATION TEST(S) (K033187)Interlab S.R.L.2003-11-19
HYDRAGEL CSF ISOFOCUSING KITS (K033277)Morax2003-11-04
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (K024162)Helena Laboratories2003-02-19
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 (K002799)Beckman Coulter, Inc.2000-10-05
K-ASSAY IGM (K993323)Kamiya Biomedical Co.1999-11-30
K-ASSAY IGA (K993213)Kamiya Biomedical Co.1999-11-23
POLYSLIT IFE KIT (K990998)Helena Laboratories1999-06-28
HYDRAGEL 6 CSF KIT (K981048)Morax1998-10-07
SPIFE IFE-6 (K973040)Helena Laboratories1998-01-02
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS (K960669)Morax1996-07-12
N-ASSAY TIA IGG (K933972)Crestat Diagnostics, Inc.1994-03-22
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC (K924769)The Binding Site, Ltd.1993-02-23
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC (K924767)The Binding Site, Ltd.1993-02-23
REP IMMUNOFIX (K923658)Helena Laboratories1992-11-02
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 (K892424)Helena Laboratories1989-06-09
PARAGON IMMUNOELECTROPHORESIS REAGENT (K823884)Beckman Instruments, Inc.1983-03-07
CORNING PARAPROTEIN SCREENING (K790667)Corning Medical & Scientific1979-07-24

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Every clearance here is in the API, with alerts when new ones post.