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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, non-selective and non-differential
510(k) Number K871098
Device Name TRYPTIC SOY AGAR
Applicant
BIO MERIEUX, INC.
421 IRMEN DR.
addison,  IL  60101
Applicant Contact micki a maxwell
Correspondent
BIO MERIEUX, INC.
421 IRMEN DR.
addison,  IL  60101
Correspondent Contact micki a maxwell
Regulation Number866.2300
Classification Product Code
JSG  
Date Received03/18/1987
Decision Date 04/03/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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