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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Amikacin
510(k) Number K052815
Device Name QMS AMIKACIN REAGENTS
Applicant
Seradyn, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Applicant Contact JACK ROGERS
Correspondent
Seradyn, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Correspondent Contact JACK ROGERS
Regulation Number862.3035
Classification Product Code
KLQ  
Date Received10/04/2005
Decision Date 11/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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