POLIOVIRUS 3 MONOCLONAL ANTIBODY— 510(k) K940017
Substantially EquivalentLight Diagnostics
FDA 510(k) clearance K940017 for POLIOVIRUS 3 MONOCLONAL ANTIBODY, 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.