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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Adenovirus 1-33
510(k) Number K864645
Device Name ADENOLEX (R) LATEX AGGLUTINATION TEST
Applicant
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Applicant Contact JULIE DEMARCO
Correspondent
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Correspondent Contact JULIE DEMARCO
Regulation Number866.3020
Classification Product Code
GOD  
Date Received11/25/1986
Decision Date 06/04/1987
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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