FDA 510(k) Application Details - K903037

Device Classification Name Reagent, Russel Viper Venom

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510(K) Number K903037
Device Name Reagent, Russel Viper Venom
Applicant GRADIPORE LTD.
200 HARRIS ST.
P.O. BOX 65
PYRMONT NSW 2009 AS
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Contact RHONDA SMYTH
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Regulation Number 864.8950

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Classification Product Code GIR
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Date Received 07/11/1990
Decision Date 12/17/1990
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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