ACTICLOT, MODEL 824

Test, Time, Prothrombin

AMERICAN DIAGNOSTICA, INC.

The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Acticlot, Model 824.

Pre-market Notification Details

Device IDK052124
510k NumberK052124
Device Name:ACTICLOT, MODEL 824
ClassificationTest, Time, Prothrombin
Applicant AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford,  CT  06902
ContactLeigh Ayres
CorrespondentLeigh Ayres
AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford,  CT  06902
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-05
Decision Date2005-10-17
Summary:summary

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