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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Theophylline
510(k) Number K900373
Device Name BIOTRACK THEOPHYLLINE 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 Number862.3880
Classification Product Code
KLS  
Date Received01/26/1990
Decision Date 05/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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