DIAGNOSTIC REAGENT SET-RPLA

Antisera, Fluorescent, All Types, Staphylococcus Spp.

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 Diagnostic Reagent Set-rpla.

Pre-market Notification Details

Device IDK855233
510k NumberK855233
Device Name:DIAGNOSTIC REAGENT SET-RPLA
ClassificationAntisera, Fluorescent, All Types, Staphylococcus Spp.
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 CodeGTN  
CFR Regulation Number866.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-31
Decision Date1986-11-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384029587 K855233 000

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