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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Microbial Growth
510(k) Number K842874
Device Name RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
Applicant
American Micro Scan
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Micro Scan
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2560
Classification Product Code
JTA  
Date Received07/23/1984
Decision Date 09/12/1984
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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