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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 K854129
Device Name ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
Applicant
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Applicant Contact DE MARCO
Correspondent
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Correspondent Contact DE MARCO
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received10/09/1985
Decision Date 01/21/1986
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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