OXOID SIGNAL BLOOD CULTURE SYSTEM

Culture Media, Non-selective And Non-differential

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 Oxoid Signal Blood Culture System.

Pre-market Notification Details

Device IDK862946
510k NumberK862946
Device Name:OXOID SIGNAL BLOOD CULTURE SYSTEM
ClassificationCulture Media, Non-selective And Non-differential
Applicant OXOID U.S.A., INC. WADE RD. BASINGSTROKE Hampshire Rg 24 Op,  GB
ContactE. Y Bridson
CorrespondentE. Y Bridson
OXOID U.S.A., INC. WADE RD. BASINGSTROKE Hampshire Rg 24 Op,  GB
Product CodeJSG  
CFR Regulation Number866.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-05
Decision Date1986-11-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384013623 K862946 000

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