BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT

Tubes, Vacuum Sample, With Anticoagulant

ORGANON TEKNIKA CORP.

The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Bact/alert Blood Collection Adapter Cap And Insert.

Pre-market Notification Details

Device IDK933939
510k NumberK933939
Device Name:BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
ClassificationTubes, Vacuum Sample, With Anticoagulant
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 CodeGIM  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-12
Decision Date1994-02-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026125769 K933939 000
03573026125752 K933939 000

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