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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K951072
Device Name PROTIME MICROCOAGULATION SYSTEM
Applicant
International Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Applicant Contact ROBERT N BORGHESE
Correspondent
International Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Correspondent Contact ROBERT N BORGHESE
Regulation Number864.5400
Classification Product Code
GKP  
Subsequent Product Code
GJS  
Date Received03/08/1995
Decision Date 10/27/1995
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
Recalls CDRH Recalls
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