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Light Diagnostics

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K991880 LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYGQN1999-11-09 View
510(k) K990141 LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295GQW1999-10-19 View
510(k) K972975 LIGHT DIAGNOSTICS RABIES DFA REAGENTGOI1998-12-22 View
510(k) K974302 LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BGNW1998-04-08 View
510(k) K951821 CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLIN1996-06-07 View
510(k) K951799 VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYGQX1996-03-20 View
510(k) K940017 POLIOVIRUS 3 MONOCLONAL ANTIBODYGOE1995-09-12 View
510(k) K940034 POLIOVIRUS 2 MONOCLONAL ANTIBODYGOE1995-09-12 View
510(k) K940026 POLIOVIRUS BLEND MONOCLONAL ANTIBODIESGOE1995-09-12 View
510(k) K940018 POLIOVIRUS 1 MONOCLONAL ANTIBODYGOE1995-09-08 View
510(k) K936253 COXSACKIEVIRUS B4 MONOCLONAL ANTIBODYGNM1995-09-08 View
510(k) K936252 COXSACKIEVIRUS B@ MONOCLONAL ANTIBODYGNM1995-09-08 View
510(k) K936251 COXSACKIEVIRUS B3 MONOCLONAL ANTIBODYGNM1995-09-08 View
510(k) K936254 COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODYGNM1995-09-08 View
510(k) K940363 ENTEROVIRUS 70 MONCLONAL ANTIBODYGOE1995-09-08 View
510(k) K944192 ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVERDBL1995-03-06 View
510(k) K944191 ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVERDBL1995-03-06 View
510(k) K935809 CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYGQH1994-05-05 View
510(k) K922801 RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAYGNY1993-01-06 View
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