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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name immunoelectrophoretic, immunoglobulins, (g, a, m)
510(k) Number K120169
Device Name INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
Original Applicant
GRIFOLS USA, LLC
482 cherry lane rd.
east stroudsburg,  PA  18301
Original Contact gary lehnus
Regulation Number866.5510
Classification Product Code
CFF  
Subsequent Product Codes
CEF   DEH   DFH  
Date Received01/19/2012
Decision Date 08/24/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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