PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M— 510(k) K073381
Substantially EquivalentFocus Diagnostics, Inc.
FDA 510(k) clearance K073381 for PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M, Substantially Equivalent on 2008-08-04. Applicant: Focus Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Focus Diagnostics, Inc.
- 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
Recent devices under product code LJN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.