HEMOCHRON RESPONSE

Instrument, Coagulation

INTERNATIONAL TECHNIDYNE CORP.

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

Pre-market Notification Details

Device IDK983475
510k NumberK983475
Device Name:HEMOCHRON RESPONSE
ClassificationInstrument, Coagulation
Applicant INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison,  NJ  08820
ContactJohn M Clay
CorrespondentJohn M Clay
INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison,  NJ  08820
Product CodeKQG  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-02
Decision Date1999-05-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10711234520062 K983475 000
10711234520055 K983475 000
10711234520017 K983475 000

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