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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 K841243
Device Name ENZYGNOST ROTAVIRUS AG
Applicant
Behring Diagnostics, Inc.
La Jolla,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
La Jolla,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received03/23/1984
Decision Date 10/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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