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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K872646
Device Name VIRON(TM)
Applicant
bioMerieux, Inc.
605 Holly St.
Easton,  PA  18042
Applicant Contact ROD KATZER
Correspondent
bioMerieux, Inc.
605 Holly St.
Easton,  PA  18042
Correspondent Contact ROD KATZER
Regulation Number862.1660
Classification Product Code
JJT  
Date Received07/06/1987
Decision Date 09/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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