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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulase, Human, Horse And Rabbit
510(k) Number K870945
Device Name RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
Applicant
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact RUTH KEMP
Correspondent
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact RUTH KEMP
Regulation Number866.2160
Classification Product Code
JTL  
Date Received03/09/1987
Decision Date 06/10/1987
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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