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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K863368
Device Name SYPH-TRUST
Applicant
I.A.F. Production, Inc.
527 Blvd. Des Prairies
P.O. Box 310, Laval
Quebec, Canada H7n4z9,  CA
Applicant Contact FRANCOIS MORIN
Correspondent
I.A.F. Production, Inc.
527 Blvd. Des Prairies
P.O. Box 310, Laval
Quebec, Canada H7n4z9,  CA
Correspondent Contact FRANCOIS MORIN
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received09/03/1986
Decision Date 12/12/1986
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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