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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K080085
Device Name MAS TOX CONTROL
Applicant
Thermo Fisher Scientific
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Applicant Contact JACK ROGERS
Correspondent
Thermo Fisher Scientific
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Correspondent Contact JACK ROGERS
Regulation Number862.3280
Classification Product Code
DIF  
Date Received01/11/2008
Decision Date 04/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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