I.M.N. LATEX

System, Test, Infectious Mononucleosis

BIOKIT USA, INC.

The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for I.m.n. Latex.

Pre-market Notification Details

Device IDK874678
510k NumberK874678
Device Name:I.M.N. LATEX
ClassificationSystem, Test, Infectious Mononucleosis
Applicant BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , 
ContactGuixer
CorrespondentGuixer
BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , 
Product CodeKTN  
CFR Regulation Number866.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-13
Decision Date1987-12-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613647001325 K874678 000
00613647001318 K874678 000
00613647001301 K874678 000
00840733101298 K874678 000

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