QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL

System, Test, C-reactive Protein

BIOKIT USA, INC.

The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Quantex Crp Plus (latex, Buffer, Standard, Control.

Pre-market Notification Details

Device IDK896272
510k NumberK896272
Device Name:QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
ClassificationSystem, Test, C-reactive Protein
Applicant BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona,  ES 08186
ContactOdriozola
CorrespondentOdriozola
BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona,  ES 08186
Product CodeDCN  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-30
Decision Date1989-11-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613647001288 K896272 000
00613647001271 K896272 000
00006136471288 K896272 000
00006136471271 K896272 000
08426950589365 K896272 000

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