RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122

Plasma, Coagulase, Human, Horse And Rabbit

OXOID U.S.A., INC.

The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Rabbit Plasma Fibrinogen Supplement Sr 122.

Pre-market Notification Details

Device IDK870945
510k NumberK870945
Device Name:RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
ClassificationPlasma, Coagulase, Human, Horse And Rabbit
Applicant OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia,  MD  21045
ContactRuth Kemp
CorrespondentRuth Kemp
OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia,  MD  21045
Product CodeJTL  
CFR Regulation Number866.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-09
Decision Date1987-06-10

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