FDA 510(k) Applications for Medical Device Product Code "LCO"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K040293 | AKERS LABORATORIES, INC. | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | 05/28/2004 |
K003767 | DIAGNOSTICA STAGO, INC. | ASSERACHROM HPIA TEST KIT | 02/12/2001 |
K983379 | GENETIC TESTING INSTITUTE | GTI-PF4 ELISA | 03/09/1999 |
K053559 | GENETIC TESTING INSTITUTE | PF4 ENHANCED SOLID PHASE ELISA | 01/20/2006 |
K071781 | GENETIC TESTING INSTITUTE | PF4 IGG | 12/19/2007 |
K071255 | HYPHEN BIOMED | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | 09/07/2007 |
K201570 | Immucor GTI Diagnostics, Inc. | PF4 Enhanced assay | 09/11/2020 |
K201311 | Immucor GTI Diagnostics, Inc. | PF4 IgG assay | 06/18/2020 |
K170854 | Instrumentation Laboratory Co. | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | 09/08/2017 |
K153137 | INSTRUMENTATION LABORATORY CO. | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | 07/08/2016 |