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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, Tobramycin
510(k) Number K832408
Device Name STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
Applicant
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3900
Classification Product Code
LCR  
Date Received07/21/1983
Decision Date 08/26/1983
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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