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DDC — Thyroglobulin, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DDC
Device Class
Class II
Regulation Number
866.5870
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K023592quest intlSERAQUEST ANTI-THYROGLOBULINJanuary 6, 2003
K012208beckman coulterACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,September 7, 2001
K000363zeus scientificMODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMFebruary 18, 2000
K991610zeus scientificZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.June 25, 1999
K991179zeus scientificZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMJune 17, 1999
K971835monobindANTI-THYROGLOBULIN (TG) MICROPLATE ELISAJuly 3, 1997
K953066fujirebio americaSERODIA ATGAugust 14, 1995
K943625cogent diagnoticsAUTOSTAT II ANTI-THYROGLOBULINDecember 22, 1994
K936010biomericaTHYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAYJuly 18, 1994
K930486inova diagnosticsQUANTA LITE(TM) THYROID T ELISAMarch 15, 1993
K865020miles laboratoriesSERA-TEK THYROGLOBULIN ANTIBODY TESTFebruary 2, 1987
K780874burroughs wellcomeTHYMUNE-TJune 14, 1978
K780873burroughs wellcomeTHYMUNE-MJune 14, 1978