FIBROTEK FIB— 510(k) K042919

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K042919 for FIBROTEK FIB, Substantially Equivalent on 2004-11-29. Applicant: R2 Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GIS
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 2004-10-22
Decision date: 2004-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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