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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K860720
Device Name BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)
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 Number862.2300
Classification Product Code
JJQ  
Date Received02/26/1986
Decision Date 05/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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