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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K844399
Device Name RESPIRALEX LATEX AGGLUTINATION TEST
Applicant
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Applicant Contact CHERYL WEST
Correspondent
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Correspondent Contact CHERYL WEST
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received11/13/1984
Decision Date 01/08/1985
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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