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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 K860719
Device Name BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
Applicant
Biotrack, Inc.
430 Oakmead Pkwy.
Sunnyvale,  CA  94086
Applicant Contact JIM ALLEN
Correspondent
Biotrack, Inc.
430 Oakmead Pkwy.
Sunnyvale,  CA  94086
Correspondent Contact JIM ALLEN
Regulation Number864.5425
Classification Product Code
JPA  
Date Received02/26/1986
Decision Date 05/23/1986
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
Recalls CDRH Recalls
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