FDA 510(k) Applications for Medical Device Product Code "DFT"
(Igm, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983132 ABBOTT LABORATORIES IGM 11/04/1998
K962201 INSTRUMENTATION LABORATORY CO. QUANTEX IGM 09/25/1996
K955797 RANDOX LABORATORIES, LTD. IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR 04/05/1996


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