THROMBONOSTIKA F1.2

Prothrombin Fragment 1.2

ORGANON TEKNIKA CORP.

The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Thrombonostika F1.2.

Pre-market Notification Details

Device IDK964934
510k NumberK964934
Device Name:THROMBONOSTIKA F1.2
ClassificationProthrombin Fragment 1.2
Applicant ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham,  NC  27712
ContactRon Sanyal
CorrespondentRon Sanyal
ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham,  NC  27712
Product CodeMIF  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-09
Decision Date1997-03-18
Summary:summary

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