PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200

Protamine Sulphate

INTERNATIONAL TECHNIDYNE CORP.

The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Protamine Response Test Catalogue Number Prt 200.

Pre-market Notification Details

Device IDK910105
510k NumberK910105
Device Name:PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
ClassificationProtamine Sulphate
Applicant INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison,  NJ  08820
ContactLes Heimann
CorrespondentLes Heimann
INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison,  NJ  08820
Product CodeGFT  
CFR Regulation Number864.7525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-03
Decision Date1991-02-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10711234202067 K910105 000
10711234202050 K910105 000
10711234102183 K910105 000

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