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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Mycoplasma Spp.
510(k) Number K903958
Device Name SEROFAST
Applicant
Intl. Mycoplasma/Mdc Assoc.
P.O. Box 641
Manchester,  MA  01944
Applicant Contact FRAN GRIGGS
Correspondent
Intl. Mycoplasma/Mdc Assoc.
P.O. Box 641
Manchester,  MA  01944
Correspondent Contact FRAN GRIGGS
Regulation Number866.3375
Classification Product Code
GSA  
Date Received08/28/1990
Decision Date 12/21/1990
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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