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LJC — Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) Class I

FDA Device Classification

Classification Details

Product Code
LJC
Device Class
Class I
Regulation Number
866.3120
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K032330thermo biostarCT OIAMarch 2, 2004
K033865dakocytomationIDEIA PCE CHLAMYDIAJanuary 21, 2004
K033079trinity biotech usaCHLAMYDIA IGG ELISA TEST SYSTEMNovember 26, 2003
K982210dade behringMODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIAJuly 9, 1998
K962558armkelCHLAMYDIA IGG ELISA TEST SYSTEMFebruary 24, 1997
K960850bio-rad laboratoriesACCESS CHLAMYDIA ASSAYFebruary 4, 1997
K955627biomerieux vitekVIDAS CHLAMYDIA BLOCKING ASSAYOctober 7, 1996
K936054abbott laboratoriesIMX SELECT CHLAMYDIAMay 30, 1996
K940564dako diagnosticsIDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATIONJanuary 11, 1996
K951010biostarCHLAMYDIA OIAOctober 7, 1995
K946276quidelQUICKVUE(R) CHLAMYDIA TESTMay 19, 1995
K935807bio-rad laboratoriesACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAYMay 19, 1995
K935393bio-rad laboratoriesCHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAYSeptember 20, 1994
K926090syvaSYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENTSeptember 30, 1993
K921747syvaMICRO TRAK XL SYSTEMOctober 1, 1992
K920503syvaSYVA MICROTRAK CHLAMYDIA EIASeptember 25, 1992
K921462syvaMICROTRAK(R) II CHLAMYDIA EIA ASSAYSeptember 25, 1992
K921321ortho diagnostic systemsORTHO CHLAMYDIA ANTIGEN ELISA TESTAugust 11, 1992
K914327savyon diagnosticsSEROELISA(TM) CHLAMYDIA IGA TEST KITJune 9, 1992
K915281savyon diagnosticsSEROLISA CHLAMYDIA IGG TEST KITMarch 23, 1992