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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 K810011
Device Name GAMMA STICK 125-1 TOBRAMYCIN RIA KIT
Applicant
Alpha Gamma Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Alpha Gamma Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3900
Classification Product Code
KLB  
Date Received01/05/1981
Decision Date 01/28/1981
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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