FDA 510(k) Applications for Medical Device Product Code "MIF"
(Prothrombin Fragment 1.2)

FDA 510(k) Number Applicant Device Name Decision Date
K042687 DADE BEHRING, INC. ENZYGNOST F+2 (MONOCLONAL) TEST KIT 12/10/2004
K964934 ORGANON TEKNIKA CORP. THROMBONOSTIKA F1.2 03/18/1997
K962176 PANBIO, INC. TPP 10/18/1996


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