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Light Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYNovember 9, 1999
K990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295October 19, 1999
K972975LIGHT DIAGNOSTICS RABIES DFA REAGENTDecember 22, 1998
K974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BApril 8, 1998
K951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYJune 7, 1996
K951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYMarch 20, 1996
K940026POLIOVIRUS BLEND MONOCLONAL ANTIBODIESSeptember 12, 1995
K940017POLIOVIRUS 3 MONOCLONAL ANTIBODYSeptember 12, 1995
K940034POLIOVIRUS 2 MONOCLONAL ANTIBODYSeptember 12, 1995
K936254COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODYSeptember 8, 1995
K940363ENTEROVIRUS 70 MONCLONAL ANTIBODYSeptember 8, 1995
K936251COXSACKIEVIRUS B3 MONOCLONAL ANTIBODYSeptember 8, 1995
K936253COXSACKIEVIRUS B4 MONOCLONAL ANTIBODYSeptember 8, 1995
K940018POLIOVIRUS 1 MONOCLONAL ANTIBODYSeptember 8, 1995
K936252COXSACKIEVIRUS B@ MONOCLONAL ANTIBODYSeptember 8, 1995
K944191ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVERMarch 6, 1995
K944192ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVERMarch 6, 1995
K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYMay 5, 1994
K922801RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAYJanuary 6, 1993