THROMBOPLASTIN.C

Test, Time, Prothrombin

AMERICAN DADE

The following data is part of a premarket notification filed by American Dade with the FDA for Thromboplastin.c.

Pre-market Notification Details

Device IDK864273
510k NumberK864273
Device Name:THROMBOPLASTIN.C
ClassificationTest, Time, Prothrombin
Applicant AMERICAN DADE P.O. BOX 25101 Santa Ana,  CA  92799
ContactKaren Darcy
CorrespondentKaren Darcy
AMERICAN DADE P.O. BOX 25101 Santa Ana,  CA  92799
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-29
Decision Date1986-11-13

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