QUANTITATIVE FIBRINOGEN ASSAY

Test, Fibrinogen

ORTHO DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Quantitative Fibrinogen Assay.

Pre-market Notification Details

Device IDK963902
510k NumberK963902
Device Name:QUANTITATIVE FIBRINOGEN ASSAY
ClassificationTest, Fibrinogen
Applicant ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan,  NJ  08869 -0606
ContactBlanche Chien
CorrespondentBlanche Chien
ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan,  NJ  08869 -0606
Product CodeGIS  
CFR Regulation Number864.7340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-27
Decision Date1996-11-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950573500 K963902 000
08426950573494 K963902 000

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