D-DIMER WELLCOTEST (HA10)

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for D-dimer Wellcotest (ha10).

Pre-market Notification Details

Device IDK915203
510k NumberK915203
Device Name:D-DIMER WELLCOTEST (HA10)
ClassificationFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
ContactKafader Ii
CorrespondentKafader Ii
WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
Product CodeDAP  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-18
Decision Date1992-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.