HEMOCHRON CITRATE APTT

Activated Partial Thromboplastin

INTERNATIONAL TECHNIDYNE CORP.

The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Citrate Aptt.

Pre-market Notification Details

Device IDK972831
510k NumberK972831
Device Name:HEMOCHRON CITRATE APTT
ClassificationActivated Partial Thromboplastin
Applicant INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison,  NJ  08820
ContactRobert H Matland
CorrespondentRobert H Matland
INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison,  NJ  08820
Product CodeGFO  
CFR Regulation Number864.7925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-30
Decision Date1997-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950915676 K972831 000
10711234103029 K972831 000

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