Company ยท US
Light Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1999. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GOE | Antisera, Fluorescent, Poliovirus 1-3 | 5 |
| GNM | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | 4 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 1 |
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | 1 |
| GOI | Antiserum, Fluorescent, Rabies Virus | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 |
| GQX | Antiserum, Cf, Varicella-Zoster | 1 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 1999 | K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY Light Diagnostics | GQN |
| Oct 19, 1999 | K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 Light Diagnostics | GQW |
| Dec 22, 1998 | K972975 | LIGHT DIAGNOSTICS RABIES DFA REAGENT Light Diagnostics | GOI |
| Apr 8, 1998 | K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B Light Diagnostics | GNW |
| Jun 7, 1996 | K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY Light Diagnostics | LIN |
| Mar 20, 1996 | K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY Light Diagnostics | GQX |
| Sep 12, 1995 | K940034 | POLIOVIRUS 2 MONOCLONAL ANTIBODY Light Diagnostics | GOE |
| Sep 12, 1995 | K940026 | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES Light Diagnostics | GOE |
| Sep 12, 1995 | K940017 | POLIOVIRUS 3 MONOCLONAL ANTIBODY Light Diagnostics | GOE |
| Sep 8, 1995 | K940363 | ENTEROVIRUS 70 MONCLONAL ANTIBODY Light Diagnostics | GOE |
| Sep 8, 1995 | K940018 | POLIOVIRUS 1 MONOCLONAL ANTIBODY Light Diagnostics | GOE |
| Sep 8, 1995 | K936254 | COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY Light Diagnostics | GNM |
| Sep 8, 1995 | K936253 | COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY Light Diagnostics | GNM |
| Sep 8, 1995 | K936252 | COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY Light Diagnostics | GNM |
| Sep 8, 1995 | K936251 | COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY Light Diagnostics | GNM |
| Mar 6, 1995 | K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER Light Diagnostics | DBL |
| Mar 6, 1995 | K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER Light Diagnostics | DBL |
| May 5, 1994 | K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY Light Diagnostics | GQH |
| Jan 6, 1993 | K922801 | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY Light Diagnostics | GNY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||