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LIG — Radioassay, Intrinsic Factor Blocking Antibody Class II

FDA Device Classification

Classification Details

Product Code
LIG
Device Class
Class II
Regulation Number
862.1810
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240800beckman coulterAccess Intrinsic Factor AbMay 3, 2024
K071346immco diagnosticsIMMULISA INTRINSIC FACTOR ANTIBODY ELISASeptember 24, 2007
K061841inova diagnosticsQUANTA LITE INTRINSIC FACTOR ELISADecember 22, 2006
K033603beckman coulterINSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODDecember 19, 2003
K993251diagnostic productsIMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6November 17, 1999
K984108abbott laboratoriesABBOTT ARCHITECT B12February 3, 1999
K903218abbott laboratoriesIMX B12August 23, 1990
K811927corning medical and scientific1F BLOCKING ANTIBODY(57 CO) RADIOASSAYApril 1, 1982