SIMPLATE PEDIATRIC

Device, Bleeding Time

ORGANON TEKNIKA CORP.

The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Simplate Pediatric.

Pre-market Notification Details

Device IDK911745
510k NumberK911745
Device Name:SIMPLATE PEDIATRIC
ClassificationDevice, Bleeding Time
Applicant ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham,  NC  27712
ContactAnn M Quinn
CorrespondentAnn M Quinn
ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham,  NC  27712
Product CodeJCA  
CFR Regulation Number864.6100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-18
Decision Date1991-08-09

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