Medical Device Manufacturer · US , Temecula , CA

Light Diagnostics - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1993
19
Total
19
Cleared
0
Denied

FDA 510(k) Regulatory Record - Light Diagnostics Microbiology

17 devices
1-17 of 17
Cleared Nov 09, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
K991880 · GQN
Microbiology · 160d
Cleared Oct 19, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · GQW
Microbiology · 273d
Cleared Dec 22, 1998
LIGHT DIAGNOSTICS RABIES DFA REAGENT
K972975 · GOI
Microbiology · 498d
Cleared Apr 08, 1998
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · GNW
Microbiology · 142d
Cleared Jun 07, 1996
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · LIN
Microbiology · 414d
Cleared Mar 20, 1996
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · GQX
Microbiology · 336d
Cleared Sep 12, 1995
POLIOVIRUS 3 MONOCLONAL ANTIBODY
K940017 · GOE
Microbiology · 616d
Cleared Sep 12, 1995
POLIOVIRUS BLEND MONOCLONAL ANTIBODIES
K940026 · GOE
Microbiology · 617d
Cleared Sep 12, 1995
POLIOVIRUS 2 MONOCLONAL ANTIBODY
K940034 · GOE
Microbiology · 616d
Cleared Sep 08, 1995
COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
K936251 · GNM
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
K936252 · GNM
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
K936253 · GNM
Microbiology · 617d
Cleared Sep 08, 1995
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
K936254 · GNM
Microbiology · 617d
Cleared Sep 08, 1995
POLIOVIRUS 1 MONOCLONAL ANTIBODY
K940018 · GOE
Microbiology · 612d
Cleared Sep 08, 1995
ENTEROVIRUS 70 MONCLONAL ANTIBODY
K940363 · GOE
Microbiology · 590d
Cleared May 05, 1994
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
K935809 · GQH
Microbiology · 154d
Cleared Jan 06, 1993
RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
K922801 · GNY
Microbiology · 210d
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