THROMBO TEK PSE, MODEL 90-480— 510(k) K082631
Substantially EquivalentR2 Diagnostics, Inc.
FDA 510(k) clearance K082631 for THROMBO TEK PSE, MODEL 90-480, Substantially Equivalent on 2008-12-17. Applicant: R2 Diagnostics, Inc..
Clearance details
- Applicant
- R2 Diagnostics, Inc.
- Product code
- Code GGP
- 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.