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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, heparin
510(k) Number K904003
Device Name HEMOCHRON(R) HEPARIN RESPONSE TEST
Applicant
INTENSIVE TECHNOLOGY, INC.
23 NEVSKY ST.
EDISON,  NJ  08820
Applicant Contact LES HEIMANN
Correspondent
INTENSIVE TECHNOLOGY, INC.
23 NEVSKY ST.
EDISON,  NJ  08820
Correspondent Contact LES HEIMANN
Regulation Number864.7525
Classification Product Code
KFF  
Date Received08/29/1990
Decision Date 11/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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