Medical Device Manufacturer · US , Temecula , CA

Light Diagnostics

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

Light Diagnostics — FDA 510(k) Submissions

Light Diagnostics has submitted 19 FDA 510(k) premarket notifications since 1993, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antisera, Fluorescent, Poliovirus 1-3, Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6, Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, Antiserum, Fluorescent, Rabies Virus, Antisera, Cf, Influenza Virus A, B, C . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
K991880 · GQN Antigen, Cf (including Cf... · Microbiology
Nov 1999 160d
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · GQW Antigen, Cf, (including... · Microbiology
Oct 1999 273d
LIGHT DIAGNOSTICS RABIES DFA REAGENT
K972975 · GOI Antiserum, Fluorescent,... · Microbiology
Dec 1998 498d
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · GNW Antisera, Cf, Influenza... · Microbiology
Apr 1998 142d
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · LIN Antisera, Conjugated... · Microbiology
Jun 1996 414d
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · GQX Antiserum, Cf,... · Microbiology
Mar 1996 336d
POLIOVIRUS 3 MONOCLONAL ANTIBODY
K940017 · GOE Antisera, Fluorescent,... · Microbiology
Sep 1995 616d
POLIOVIRUS BLEND MONOCLONAL ANTIBODIES
K940026 · GOE Antisera, Fluorescent,... · Microbiology
Sep 1995 617d
POLIOVIRUS 2 MONOCLONAL ANTIBODY
K940034 · GOE Antisera, Fluorescent,... · Microbiology
Sep 1995 616d
COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
K936251 · GNM Antisera, Fluorescent,... · Microbiology
Sep 1995 617d
COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
K936252 · GNM Antisera, Fluorescent,... · Microbiology
Sep 1995 617d
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
K936253 · GNM Antisera, Fluorescent,... · Microbiology
Sep 1995 617d
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
K936254 · GNM Antisera, Fluorescent,... · Microbiology
Sep 1995 617d
POLIOVIRUS 1 MONOCLONAL ANTIBODY
K940018 · GOE Antisera, Fluorescent,... · Microbiology
Sep 1995 612d
ENTEROVIRUS 70 MONCLONAL ANTIBODY
K940363 · GOE Antisera, Fluorescent,... · Microbiology
Sep 1995 590d
ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
K944191 · DBL Multiple Autoantibodies,... · Immunology
Mar 1995 189d
ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER
K944192 · DBL Multiple Autoantibodies,... · Immunology
Mar 1995 189d
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
K935809 · GQH Antigen, Cf (including Cf... · Microbiology
May 1994 154d
RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
K922801 · GNY Antisera, Fluorescent,... · Microbiology
Jan 1993 210d
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