IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT— 510(k) K103757

Name: FDA 510(k) clearance K103757
Creator: U.S. Food and Drug Administration
Published: 2011-10-13

Substantially Equivalent

Grifols

FDA 510(k) clearance K103757 for IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT, Substantially Equivalent on 2011-10-13. Applicant: Grifols. Device class: 2.

Clearance details

Applicant: Grifols
Product code: Code CFF
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2010-12-23
Decision date: 2011-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

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