NOFACT VIII— 510(k) K102851

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K102851 for NOFACT VIII, Substantially Equivalent on 2011-12-19. Applicant: R2 Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2010-09-29
Decision date: 2011-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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