Product code CFF

Device name: Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5510
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K203184	HYDRASHIFT 2/4 isatuximab	Sebia	2021-11-12
K192095	CAPI 3 Immunotyping, Capillarys 3 Tera	Sebia	2019-11-01
K190851	HYDRASHIFT 2/4 daratumumab	Sebia	2019-05-02
K172195	HYDRASHIFT 2/4 daratumumab, daratumumab Control	Sebia	2018-01-11
K161928	CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL	Sebia	2016-12-21
K143483	MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING	Sebia	2015-01-08
K120169	INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT	Grifols USA, LLC	2012-08-24
K111369	THE HELENA V8 IMMUNODISPLACEMENT KIT	Helena Laboratories Uk, Ltd.	2012-06-26
K103757	IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT	Grifols	2011-10-13
K082085	CAPILLARYS IMMUNOTYPING, MODEL 2100	Sebia	2009-04-17
K082388	MINICAP IMMUNOTYPING, MODEL: 2300	Sebia	2009-04-14
K061069	SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458	Helena Laboratories	2006-07-06
K033187	INTERLAB IMMUNOFIXATION TEST(S)	Interlab S.R.L.	2003-11-19
K033277	HYDRAGEL CSF ISOFOCUSING KITS	Morax	2003-11-04
K024162	SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389	Helena Laboratories	2003-02-19
K002799	PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100	Beckman Coulter, Inc.	2000-10-05
K993323	K-ASSAY IGM	Kamiya Biomedical Co.	1999-11-30
K993213	K-ASSAY IGA	Kamiya Biomedical Co.	1999-11-23
K990998	POLYSLIT IFE KIT	Helena Laboratories	1999-06-28
K981048	HYDRAGEL 6 CSF KIT	Morax	1998-10-07
K973040	SPIFE IFE-6	Helena Laboratories	1998-01-02
K960669	HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS	Morax	1996-07-12
K933972	N-ASSAY TIA IGG	Crestat Diagnostics, Inc.	1994-03-22
K924767	IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC	The Binding Site, Ltd.	1993-02-23
K924769	IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC	The Binding Site, Ltd.	1993-02-23
K923658	REP IMMUNOFIX	Helena Laboratories	1992-11-02
K892424	REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178	Helena Laboratories	1989-06-09
K823884	PARAGON IMMUNOELECTROPHORESIS REAGENT	Beckman Instruments, Inc.	1983-03-07
K790667	CORNING PARAPROTEIN SCREENING	Corning Medical & Scientific	1979-07-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
M52518210	V8 Gel IFE Diluent Barcode Labels	HELENA LABORATORIES CORPORATION	2016-09-30
M52518030	V8 Immunodisplacement Kit	HELENA LABORATORIES CORPORATION	2016-09-24
M5255525590	SPIFE ImmunoFix-15 Gel Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M52512580	QuickGel Disposable IFE Sample Cup Strips	HELENA LABORATORIES CORPORATION	2016-09-07
M5255524720	QuickGel IFE Applicator Blades and Sample Cups	HELENA LABORATORIES CORPORATION	2016-09-07
M5255524570	SPIFE IgG IEF-10 Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255524540	QuickGel IFE Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255524400	SPIFE 4000 IFE Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255523980	SPIFE 4000 IFE Gel Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255523920	SPIFE ImmunFix-15 Urine Accessory Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255523910	SPIFE ImmunoFix-9 Urine Accessory Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255523880	SPIFE ImmunoFix-3/6 Urine Accessory Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255523070	QuickGel IFE Gel Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255522890	SPIFE ULTRA IFE-6 ANTISERA KIT	HELENA LABORATORIES CORPORATION	2016-09-07
M5255522290	SPIFE IFE-9 Pentavalent Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255522020	SPIFE IgG IEF-20 Reagent Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255521640	SPIFE Ultra ImmunoFix-9 Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255521630	SPIFE Ultra ImmunoFix-6 Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255521560	QuickGel IFE Blotter A and Templates	HELENA LABORATORIES CORPORATION	2016-09-07
M5255521250	SPIFE Ultra ImmunoFix-15 Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255521240	SPIFE IFE Applicator Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255520920	SPIFE ImmunoFix-15 Applicator Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255520890	SPIFE IgG IEF Kit, Part 2	HELENA LABORATORIES CORPORATION	2016-09-07
M5255518500	SPIFE ImmunoFix-9/15 Applicator Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255518410	SPIFE ImmunoFix-9 Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255518320	SPIFE ImmunoFix-3 Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255518220	SPIFE ImmunoFix-6 Antisera Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M5255517160	SPIFE ImmunoFix-3/6 Applicator Kit	HELENA LABORATORIES CORPORATION	2016-09-07
M52551210	Citrate Buffer	HELENA LABORATORIES CORPORATION	2016-09-07
M52533850	SPIFE IgG IEF-20 Kit	HELENA LABORATORIES CORPORATION	2016-09-07

Product code CFF

Related 510(k) Records#

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