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CFF — Immunoelectrophoretic, Immunoglobulins, (G, A, M) Class II

FDA Device Classification

Classification Details

Product Code
CFF
Device Class
Class II
Regulation Number
866.5510
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K120169grifols usaINTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENTAugust 24, 2012
K111369helena laboratories ukTHE HELENA V8 IMMUNODISPLACEMENT KITJune 26, 2012
K103757grifolsIMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENTOctober 13, 2011
K082085sebiaCAPILLARYS IMMUNOTYPING, MODEL 2100April 17, 2009
K082388sebiaMINICAP IMMUNOTYPING, MODEL: 2300April 14, 2009
K061069helena laboratoriesSPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SJuly 6, 2006
K033187interlabINTERLAB IMMUNOFIXATION TEST(S)November 19, 2003
K033277moraxHYDRAGEL CSF ISOFOCUSING KITSNovember 4, 2003
K024162helena laboratoriesSPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389February 19, 2003
K002799beckman coulterPARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100October 5, 2000
K993323kamiya biomedicalK-ASSAY IGMNovember 30, 1999
K993213kamiya biomedicalK-ASSAY IGANovember 23, 1999
K990998helena laboratoriesPOLYSLIT IFE KITJune 28, 1999
K981048moraxHYDRAGEL 6 CSF KITOctober 7, 1998