PROTHROMBIN TIME TEST

Test, Time, Prothrombin

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Prothrombin Time Test.

Pre-market Notification Details

Device IDK872537
510k NumberK872537
Device Name:PROTHROMBIN TIME TEST
ClassificationTest, Time, Prothrombin
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactDebra Hofmeister
CorrespondentDebra Hofmeister
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-25
Decision Date1987-08-27

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