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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 K822657
Device Name EMIT-AMD AMIKACIN ASSAY
Applicant
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact YUK-TING LEWIS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact YUK-TING LEWIS
Regulation Number862.3035
Classification Product Code
KLQ  
Date Received09/03/1982
Decision Date 09/28/1982
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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