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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, selective and non-differential
510(k) Number K872689
Device Name IAFP SABOURAUD DEXTROSE AGAR
Original Applicant
I.A.F. PRODUCTION, INC.
527, boul. des prairies
laval, que. h7n-423,  CA
Original Contact francois morin
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received07/07/1987
Decision Date 08/11/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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