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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 K042248
Device Name KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
Applicant
Kronus Market Development Associates, Inc.
12554 W. Bridger St.
Suite 108
Boise,  ID  83713
Applicant Contact HEATHER VIELE
Correspondent
Kronus Market Development Associates, Inc.
12554 W. Bridger St.
Suite 108
Boise,  ID  83713
Correspondent Contact HEATHER VIELE
Regulation Number866.5660
Classification Product Code
NST  
Date Received08/19/2004
Decision Date 12/17/2004
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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