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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 K962819
Device Name GENTAMICIN FLEX REAGENT CARTRIDGE
Applicant
DADE INTL., INC.
BUILDING 500, MAILBOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact CAROLYN K GEORGE
Correspondent
DADE INTL., INC.
BUILDING 500, MAILBOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.3450
Classification Product Code
LCD  
Date Received07/19/1996
Decision Date 09/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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