LUPOTEK KCT— 510(k) K090105

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K090105 for LUPOTEK KCT, Substantially Equivalent on 2010-12-30. Applicant: R2 Diagnostics, Inc..

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GGW
Advisory panel: Hematology
Date received: 2009-01-15
Decision date: 2010-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.