FDA.reportPublic FDA data

510(k) K082085

Device
CAPILLARYS IMMUNOTYPING, MODEL 2100
Applicant
Sebia
510(k) number
K082085
Product code
CFF
Decision
Substantially Equivalent (SESE)
Decision date
2009-04-17
Date received
2008-07-23
Regulation
866.5510
Classification name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KAREN ANDERSON
Address
400-1705 Corporate Dr. Suite 400 Norcross GA US 30093 30093

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203184HYDRASHIFT 2/4 isatuximabSebia2021-11-12
K192095CAPI 3 Immunotyping, Capillarys 3 TeraSebia2019-11-01
K190851HYDRASHIFT 2/4 daratumumabSebia2019-05-02
K172195HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebia2018-01-11
K161928CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROLSebia2016-12-21
K143483MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGSebia2015-01-08
K120169INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENTGrifols USA, LLC2012-08-24
K111369THE HELENA V8 IMMUNODISPLACEMENT KITHelena Laboratories Uk, Ltd.2012-06-26
K103757IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENTGrifols2011-10-13
K082388MINICAP IMMUNOTYPING, MODEL: 2300Sebia2009-04-14
K061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458Helena Laboratories2006-07-06
K033187INTERLAB IMMUNOFIXATION TEST(S)Interlab S.R.L.2003-11-19
K033277HYDRAGEL CSF ISOFOCUSING KITSMorax2003-11-04
K024162SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389Helena Laboratories2003-02-19
K002799PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100Beckman Coulter, Inc.2000-10-05