PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G— 510(k) K073382
Substantially EquivalentFocus Diagnostics, Inc.
FDA 510(k) clearance K073382 for PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G, Substantially Equivalent on 2008-07-28. Applicant: Focus Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Focus Diagnostics, Inc.
- Product code
- Code LSE
- 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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More clearances from Focus Diagnostics, Inc.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.