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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
510(k) Number K051144
Device Name ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
Applicant
IBL-HAMBURG GMBH
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
IBL-HAMBURG GMBH
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number866.5660
Classification Product Code
NST  
Date Received05/04/2005
Decision Date 11/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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