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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Tobramycin
510(k) Number K780934
Device Name IN VITRO TOBRAMYCIN RIA KIT
Applicant
Clinical Assays, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Clinical Assays, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3900
Classification Product Code
KLB  
Date Received06/08/1978
Decision Date 08/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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