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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 K854090
Device Name DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
Applicant
DIATECH, INC.
4101 S. HOSPITAL DR.
FORT LAUDERDALE,  FL  33317
Applicant Contact BETTY L WHITE
Correspondent
DIATECH, INC.
4101 S. HOSPITAL DR.
FORT LAUDERDALE,  FL  33317
Correspondent Contact BETTY L WHITE
Regulation Number864.5425
Classification Product Code
JPA  
Date Received10/07/1985
Decision Date 01/06/1986
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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