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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, amikacin
510(K) Number K802877
Device Name AMIKACIN RIA KIT
Applicant
ANTIBODIES INC.
Regulation Number862.3035
Classification Product Code
KLQ  
Date Received11/17/1980
Decision Date 12/19/1980
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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