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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K860721
Device Name BIOTRACK PROTIME TEST PROTHROMBIN TIME 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 Number864.7750
Classification Product Code
GJS  
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
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