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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Gentamicin
510(k) Number K823387
Device Name SOPHEIA GENTAMICIN EIA KIT
Applicant
Diagnostic Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diagnostic Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3450
Classification Product Code
LCD  
Date Received11/15/1982
Decision Date 12/22/1982
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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