HEMONIR TM— 510(k) K050014

Substantially Equivalent

Nir Diagnostics, Inc.

FDA 510(k) clearance K050014 for HEMONIR TM, Substantially Equivalent on 2005-05-05. Applicant: Nir Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Nir Diagnostics, Inc.
Product code: Code GLY
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 2005-01-03
Decision date: 2005-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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