INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT— 510(k) K120169

Name: FDA 510(k) clearance K120169
Creator: U.S. Food and Drug Administration
Published: 2012-08-24

Substantially Equivalent

Grifols USA, LLC

FDA 510(k) clearance K120169 for INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT, Substantially Equivalent on 2012-08-24. Applicant: Grifols USA, LLC. Device class: 2.

Clearance details

Applicant: Grifols USA, LLC
Product code: Code CFF
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2012-01-19
Decision date: 2012-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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