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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Enterobacteriaceae
510(k) Number K771703
Device Name ENTERIC 20
Applicant
Inolex Corp./Div of Biomedical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Inolex Corp./Div of Biomedical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2660
Classification Product Code
JSS  
Date Received09/09/1977
Decision Date 10/04/1977
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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