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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 K103757
Device Name IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
Applicant
Grifols
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Grifols
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number866.5510
Classification Product Code
CFF  
Subsequent Product Codes
CEF   DEH   DFH  
Date Received12/23/2010
Decision Date 10/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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