TPP

Prothrombin Fragment 1.2

PANBIO, INC.

The following data is part of a premarket notification filed by Panbio, Inc. with the FDA for Tpp.

Pre-market Notification Details

Device IDK962176
510k NumberK962176
Device Name:TPP
ClassificationProthrombin Fragment 1.2
Applicant PANBIO, INC. 1539 N. IRONWOOD DR. South Bend,  IN  46635
ContactChristopher Notestine
CorrespondentChristopher Notestine
PANBIO, INC. 1539 N. IRONWOOD DR. South Bend,  IN  46635
Product CodeMIF  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-05
Decision Date1996-10-18
Summary:summary

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