EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY— 510(k) K931520
Substantially EquivalentMrl Diagnostics
FDA 510(k) clearance K931520 for EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY, Substantially Equivalent on 1994-04-26. Applicant: Mrl Diagnostics. Device class: 1.
Clearance details
- Applicant
- Mrl Diagnostics
- Product code
- Code LJN
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.