HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE

System, Multipurpose For In Vitro Coagulation Studies

INTERNATIONAL TECHNIDYNE CORP.

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

Pre-market Notification Details

Device IDK990449
510k NumberK990449
Device Name:HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison,  NJ  08820
ContactJohn Clay
CorrespondentJohn Clay
INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison,  NJ  08820
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-12
Decision Date1999-04-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10711234540060 K990449 000
10711234540053 K990449 000
10711234540114 K990449 000

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