NOFACT IX— 510(k) K102908

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K102908 for NOFACT IX, Substantially Equivalent on 2011-12-19. Applicant: R2 Diagnostics, Inc..

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GJT
Advisory panel: Hematology
Date received: 2010-10-01
Decision date: 2011-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

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