LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA— 510(k) K083878
Substantially EquivalentR2 Diagnostics, Inc.
FDA 510(k) clearance K083878 for LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA, Substantially Equivalent on 2010-06-25. Applicant: R2 Diagnostics, Inc..
Clearance details
- Applicant
- R2 Diagnostics, Inc.
- Product code
- Code GIR
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Bend, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.