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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 K102699
Device Name ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Dept 9v6 Ap6c-2
Abbott Park,  IL  60064
Applicant Contact JUDITH WALLACH
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Dept 9v6 Ap6c-2
Abbott Park,  IL  60064
Correspondent Contact JUDITH WALLACH
Regulation Number862.3450
Classification Product Code
LCD  
Subsequent Product Code
DLJ  
Date Received09/20/2010
Decision Date 04/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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