T-TEK— 510(k) K050817

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K050817 for T-TEK, Substantially Equivalent on 2005-12-12. Applicant: R2 Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 2005-03-31
Decision date: 2005-12-12
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.