K082631

Substantially Equivalent

THROMBO TEK PSE, MODEL 90-480

Applicant: R2 Diagnostics, Inc.
Product code: GGP
Advisory panel: Hematology
Date received: 2008-09-10
Decision date: 2008-12-17
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.