Light Diagnostics
Temecula, CA, US
Light Diagnostics appears in FDA device records in Temecula, CA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Light Diagnostics between 1993 and 1999. The busiest year on record is 1995, with 11. The most recent is 1999, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 11 |
| 1996 | 2 |
| 1998 | 2 |
| 1999 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | GQN | Substantially Equivalent | |
| K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | GQW | Substantially Equivalent | |
| K972975 | LIGHT DIAGNOSTICS RABIES DFA REAGENT | GOI | Substantially Equivalent | |
| K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | GNW | Substantially Equivalent | |
| K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | LIN | Substantially Equivalent | |
| K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | GQX | Substantially Equivalent | |
| K940034 | POLIOVIRUS 2 MONOCLONAL ANTIBODY | GOE | Substantially Equivalent | |
| K940026 | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | GOE | Substantially Equivalent | |
| K940017 | POLIOVIRUS 3 MONOCLONAL ANTIBODY | GOE | Substantially Equivalent | |
| K940363 | ENTEROVIRUS 70 MONCLONAL ANTIBODY | GOE | Substantially Equivalent | |
| K940018 | POLIOVIRUS 1 MONOCLONAL ANTIBODY | GOE | Substantially Equivalent | |
| K936254 | COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY | GNM | Substantially Equivalent | |
| K936253 | COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY | GNM | Substantially Equivalent | |
| K936252 | COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY | GNM | Substantially Equivalent | |
| K936251 | COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY | GNM | Substantially Equivalent | |
| K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | DBL | Substantially Equivalent | |
| K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | DBL | Substantially Equivalent | |
| K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY | GQH | Substantially Equivalent | |
| K922801 | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY | GNY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
- GNWAntisera, Cf, Influenza Virus A, B, C
- LINAntisera, Conjugated Fluorescent, Cytomegalovirus
- GNYAntisera, Fluorescent, Adenovirus 1-33
- GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
- GOEAntisera, Fluorescent, Poliovirus 1-3
- GQXAntiserum, Cf, Varicella-Zoster
- GOIAntiserum, Fluorescent, Rabies Virus
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain