Medical Device Manufacturer · US , Temecula , CA

Light Diagnostics - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1993

Recent clearances: LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY, LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295, LIGHT DIAGNOSTICS RABIES DFA REAGENT

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Light Diagnostics Microbiology ✕

17 devices

1-12 of 17

Cleared Nov 09, 1999

LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY

Microbiology · 160d

Cleared Oct 19, 1999

LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295

Microbiology · 273d

Cleared Dec 22, 1998

LIGHT DIAGNOSTICS RABIES DFA REAGENT

Microbiology · 498d

Cleared Apr 08, 1998

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B

Microbiology · 142d

Cleared Jun 07, 1996

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

Microbiology · 414d

Cleared Mar 20, 1996

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

Microbiology · 336d

Cleared Sep 12, 1995

POLIOVIRUS 3 MONOCLONAL ANTIBODY

Microbiology · 616d

Cleared Sep 12, 1995

POLIOVIRUS BLEND MONOCLONAL ANTIBODIES

Microbiology · 617d

Cleared Sep 12, 1995

POLIOVIRUS 2 MONOCLONAL ANTIBODY

Microbiology · 616d

Cleared Sep 08, 1995

COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY

Microbiology · 617d

Cleared Sep 08, 1995

COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY

Microbiology · 617d

Cleared Sep 08, 1995

COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY

Microbiology · 617d