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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
Predetermined Change
Control Plan Authorized		 No
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