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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 Ln. Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Ibl-Hamburg GmbH
150 Cherry Ln. 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
Predetermined Change
Control Plan Authorized		 No
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