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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K870831
Device Name PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
Applicant
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Applicant Contact MICHAEL D MINTZ
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Correspondent Contact MICHAEL D MINTZ
Regulation Number864.5425
Classification Product Code
JPA  
Date Received03/03/1987
Decision Date 06/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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