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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, General Purpose, Microbiology, Diagnostic
510(k) Number K872273
Device Name CORNING EASY WASH ELISA PLATES
Applicant
Corning Medical & Scientific
275 River St.
Oneonta,  NY  13820
Applicant Contact BARBARA L MULLIN
Correspondent
Corning Medical & Scientific
275 River St.
Oneonta,  NY  13820
Correspondent Contact BARBARA L MULLIN
Regulation Number866.2660
Classification Product Code
LIB  
Date Received06/15/1987
Decision Date 07/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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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