POLIOVIRUS BLEND MONOCLONAL ANTIBODIES— 510(k) K940026
Substantially EquivalentLight Diagnostics
FDA 510(k) clearance K940026 for POLIOVIRUS BLEND MONOCLONAL ANTIBODIES, Substantially Equivalent on 1995-09-12. Applicant: Light Diagnostics. Device class: 1.
Clearance details
- Applicant
- Light Diagnostics
- Product code
- Code GOE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3405
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temecula, CA, US
Recent devices under product code GOE
view allMore clearances from Light Diagnostics
view all- K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
- K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
- K972975 — LIGHT DIAGNOSTICS RABIES DFA REAGENT
- K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
- K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.