CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY— 510(k) K935809
Substantially EquivalentLight Diagnostics
FDA 510(k) clearance K935809 for CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY, Substantially Equivalent on 1994-05-05. Applicant: Light Diagnostics. Device class: 2.
Clearance details
- Applicant
- Light Diagnostics
- Product code
- Code GQH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temecula, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.