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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Vancomycin
510(k) Number K050419
Device Name QMS VANCOMYCIN
Applicant
Seradyn, Inc.
7998 Georgetown Rd.
Indianapolis,  IN  46268
Applicant Contact JACK ROGERS
Correspondent
Seradyn, Inc.
7998 Georgetown Rd.
Indianapolis,  IN  46268
Correspondent Contact JACK ROGERS
Regulation Number862.3950
Classification Product Code
LEH  
Date Received02/18/2005
Decision Date 04/01/2005
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
Recalls CDRH Recalls
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