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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo, Alt/Sgpt
510(k) Number K895128
Device Name BIOTRACK ALT TEST CARTRIDGE
Applicant
Biotrack, Inc.
1058 Huff Ave.
Mountain View,  CA  94043
Applicant Contact JILL FINDLAY
Correspondent
Biotrack, Inc.
1058 Huff Ave.
Mountain View,  CA  94043
Correspondent Contact JILL FINDLAY
Regulation Number862.1030
Classification Product Code
CJJ  
Date Received08/17/1989
Decision Date 10/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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