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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K870151
Device Name TOTAL/IGE THEOPHYLLINE CONTROL SERA
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 Number862.1660
Classification Product Code
JJX  
Date Received01/13/1987
Decision Date 03/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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