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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Theophylline
510(k) Number K863475
Device Name THEOFAST(TM) TEST PACKAGE
Applicant
3M Company
1500 Salado Dr.
Mountain View,  CA  94043
Applicant Contact ALEXANDER A MONTE
Correspondent
3M Company
1500 Salado Dr.
Mountain View,  CA  94043
Correspondent Contact ALEXANDER A MONTE
Regulation Number862.3880
Classification Product Code
LER  
Date Received09/09/1986
Decision Date 11/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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