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510(k) K924769

Device
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
Applicant
THE BINDING SITE, LTD.
510(k) number
K924769
Product code
CFF  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-23
Date received
1992-09-23
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
JAY H GELLER
Address
Westside Towers, Suite 1000 11845 W. Olympic Blvd. Los Angeles CA US 90064 90064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CFF  #

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
K082085CAPILLARYS IMMUNOTYPING, MODEL 2100Sebia2009-04-17
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

Legacy Summary#

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FDA Review#

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