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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Multiple Biochemical Test
510(k) Number K841204
Device Name MULTIPLE BIOCHEMICAL TEST
Applicant
Smith River Biologicals
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Smith River Biologicals
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2320
Classification Product Code
JSE  
Date Received03/12/1984
Decision Date 04/17/1984
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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