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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Poliovirus 1-3
510(k) Number K940027
Device Name ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
Applicant
Chemicon Intl., Inc.
28835 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact RICHARD P TRIGLIA
Correspondent
Chemicon Intl., Inc.
28835 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact RICHARD P TRIGLIA
Regulation Number866.3405
Classification Product Code
GOE  
Date Received01/03/1994
Decision Date 09/12/1995
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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