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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 K831643
Device Name STRIPREADER MICROELISA SYSTEM
Applicant
Organon Teknika Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Organon Teknika Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2660
Classification Product Code
LIB  
Date Received05/23/1983
Decision Date 07/26/1983
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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