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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bacillus Subtilis Microbiology Assay, Tobramycin
510(k) Number K802038
Device Name PHENYTOIN REAGENT TEST KIT
Applicant
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3900
Classification Product Code
DID  
Date Received08/25/1980
Decision Date 10/23/1980
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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