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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rotavirus
510(k) Number K861172
Device Name ROTAVIRUS LATEX AGGLUTINATION ASSAY
Applicant
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact HOWARD TAYLOR
Correspondent
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact HOWARD TAYLOR
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received03/28/1986
Decision Date 07/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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