MODIFIED RUBAGEN

Latex Agglutination Assay, Rubella

BIOKIT USA, INC.

The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Modified Rubagen.

Pre-market Notification Details

Device IDK896433
510k NumberK896433
Device Name:MODIFIED RUBAGEN
ClassificationLatex Agglutination Assay, Rubella
Applicant BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona,  ES
ContactIgnacio Odriozola
CorrespondentIgnacio Odriozola
BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona,  ES
Product CodeLQN  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-09
Decision Date1989-11-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613647001226 K896433 000
00613647001219 K896433 000
08426950590569 K896433 000
00006136471226 K896433 000
00006136471219 K896433 000

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